Abstract
Background Amandys is a pyrocarbon interposition implant used as a therapeutic alternative to total wrist fusion (TWF) or total wrist arthroplasty (TWA) in painful and disabling extensive destruction of the wrist.
Objective To review mid-term outcomes in a continuous prospective series of patients who underwent wrist arthroplasty Amandys with a minimum follow-up of 5 years.
Methods Clinical evaluation included a satisfaction survey, pain, two functional scores, the short version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and the Patient-Rated Wrist Evaluation (PRWE), active wrist mobility, and grip strength compared with the contralateral side. Radiological evaluation was used to detect implant subsidence, carpal migration, bone lysis, or implant malposition. All per- and postoperative complications were collected.
Results Fifty-nine patients (63 procedures) were evaluated with a mean follow-up of 7 years; 57% of the patients were males, and the mean age was 58 years. Among the patients, 90% were satisfied or very satisfied. Pain was significantly improved, with a gain of 4/10 ( p < 0.001). Functional outcomes also improved between the second and fifth year of follow-up. Active mobility was preserved and grip strength was significantly improved by 7 kg ( p < 0.001). No implant subsidence or carpal migration was observed. Ten patients (11.9%) underwent revision surgery for conflict (1%), rotation (6%), or implant dislocation (5%). All complications and revisions occurred early with no new events after 1 year of follow-up.
Discussion Mid-term clinical and radiological outcomes were stable with improvement of functional scores. The survival rate was comparable to that reported for TWF with conserved mobility. We report fewer complications compared with those reported for TWA or TWF. Early instability of the implant was the main etiology of the revisions. Repositioning of the implant was successful. No conversion to TWA or TWF was necessary.
Conclusions Mid-term outcomes of the Amandys implants were encouraging. Patients conserved good wrist motion with improved strength and functional scores. The implant was well tolerated. Functional outcomes continue to improve with the follow-up. The survival rate remains stable after 2 years. The level of evidence of this study is IV (therapeutic case series).
Keywords: wrist arthroplasty, pyrocarbon implant, Amandys, osteoarthritis, interposition
The therapeutic management of major wrist destruction is challenging. Such destruction results in a significant impact on pain, grip strength, and wrist mobility. Wrist denervation, total wrist fusion (TWF), or total wrist arthroplasty (TWA) remain the main therapeutic options, 1 with relevant outcomes on long-term follow-up. 2 3 These options may improve pain and grip strength, but also change or compromise the range of motion (ROM). Their survival rates are variable. Denervation only temporarily improves pain without affecting joint mobility, grip strength, or radiological changes. 4 5 6 7 Studies on TWF and especially TWA have shown a decline in long-term survival, even when the preliminary results were favorable. Amandys is a pyrocarbon implant used as an interposition arthroplasty. This last generation of wrist motion-preserving procedures has been proposed as therapeutic alternative to TWF and TWP for extended wrist destruction. Preliminary and short-term outcomes of Amandys were encouraging. 8 9 10 However, the medium- and long-term outcomes have not yet been reported.
The purpose of this study was to report the clinical and radiological outcomes with Amandys implants with a minimum follow-up of 5 years.
Our main hypothesis was to have good mid-term outcomes with Amandys implant. Our secondary hypotheses were to have stable mid-term outcomes compared with those in short term and a survival rate comparable to those for TWF or TWA.
Materials and Methods
We evaluated a continuous, prospective, single-center study of all patients with interposition arthroplasty using an Amandys implant between November 2008 and October 2013 performed by four senior hand surgeons. 11 The inclusion criterion was: all patients who operated on with an Amandys implant with a minimum follow-up of 5 years.
Implant Description
Amandys (Wright Medical-Tornier, SAS, Bioprofile, Grenoble, France) is a pyrocarbon implant for radiocarpal interposition arthroplasty. It replaces two-thirds of the proximal scaphoid, the lunatum, and a portion of the capitate head. It preserves the triquetrum and the distal third of the scaphoid, and thus the main extrinsic wrist ligaments.
The implant is quadri-elliptic in shape. The two convex joint surfaces are asymmetrical, with the radial surface being more pronounced than those of the midcarpal surface. It is a mobile spacer with no bone or ligament fixation. Its stability is ensured by its congruence with bone surfaces of the radius and the midcarpus, laterally by bone contours of triquetrum and radial styloid, and by the anterior and posterior capsuloligamentous structures of the wrist.
Amandys is available in eight sizes depending on length (24 or 26 mm) and thickness (S, M, L, and XL).
Operating Technique
The arthroplasty was performed under locoregional anesthesia using an arm tourniquet. Two approaches were used: dorsal or radial. 8
Dorsal Approach
This approach was used if removal of material, capsular reinforcement, or bone reconstruction was planned. The incision was italic “S-shaped.” The annular ligament was incised next to the fourth extensor compartment. The capsulotomy was longitudinal or with a capsular flap according to Berger. 12
Radial Approach
This approach was used in virgin wrists without major osteoarticular destruction and if no capsular reinforcement was envisaged. The wrist was placed in a lateral position with a support under the ulnar side to allow ulnar inclination. An “S-shaped” incision of approximately 5 cm was made on the radial wrist opposite the radial styloid and the anatomical snuffbox. The sensitive branch of the radial nerve was protected. The capsulotomy was longitudinal between the first and second compartments. 8
Bone Preparation
A 5-mm partial styloidectomy was achieved with an oscillating saw, parallel to the frontal slope and parallel to the glenoid facet of the radius. A partial resection of the scaphoid was performed with the oscillating saw at the junction of the proximal two-thirds and the distal third. The slice's orientation was parallel to sagittal and coronal slopes of the radius. Resection of the lunatum was performed after releasing it from all the capsuloligamentous attachments taking care not to damage the anterior and posterior capsules. The final step, a partial resection of the capitate, was performed, continuous with the scaphoidectomy. 8
The glenoid surface of the radius was prepared using the ovoid burr until a homogeneous ovoid surface was obtained by collapsing the ridge separating the lunate and scaphoid fossae. On the carpal slope, the same burr was used to obtain a slightly concave homogeneous surface. Voluminous osteophytes could be resected at the same time, taking care to preserve capsuloligamentous insertions. A synovectomy could be performed, if necessary, at the end, and the capsular surface was inspected to repair any breach or plicated, in the case of distension, by suture reinforcement points.
Implants
The size of the implant required was determined using preoperative templates. The implant comes in eight sizes, varying in length (24 or 26 mm) and thickness (S, M, L, and XL). The final size was chosen preoperative under fluoroscopic examination. Different criteria had to be defined to determine the correct size. 8
Passive flexion–extension is obtained using gravity alone, and ulnar and radial inclinations are complete.
The implant does not rotate on its vertical axis (a sign that the implant is too long or impinges on bony spur) and there is no cam effect with the lateral structures.
The implant does not tend to dislocate anteriorly or posteriorly (a sign of incongruence with the radial surface, either insufficient concavity of the radial glenoid or by lack of implant thickness).
There is no dorsal subluxation of the second carpal row (a sign of capsular failure by rupture or distension).
The interval between the ulna and the triquetrum is not altered compared with preoperative views (a sign of the implant that is too thick or too thin).
There is no styloscaphoid conflict.
Closure and Postoperative Care
Capsular closure was achieved using resorbable 3–0 or 4–0 suture. In the case of fragility of the capsule, it was reinforced dorsally by a flap from the dorsal retinaculum passed deeply to the extensor or a flap from the first extensor compartment if the approach was radial.
The wrist was immobilized in neutral position by a splint during the first 15 days, then gentle active mobilization of the wrist is started and a protective splint is worn at night and during the day at intervals until the 4th week. Physical therapy could then be started, adapted to each case. No particular restrictions were imposed beyond the 6th week. 8
Population
Population characteristics were collected, including etiology, age, sex, occupational status, work accidents, and surgical history involving the wrist in question.
Evaluation
All patients were evaluated at inclusion by the operator, then re-evaluated at months 1, 3, 6, 12, and 18 and at years 2, 3, and 5. The intermediate and last clinical and radiological assessments were conducted by an independent reviewer with a minimum follow-up of 5 years.
Satisfaction
Satisfaction was noted by the patient as: very satisfied, satisfied, fairly satisfied, or unsatisfied.
Clinical Evaluation
Measurements for both wrists were recorded. Active mobility in flexion, extension, radial and ulnar inclination, and pronosupination was measured using a goniometer.
Grip strength was measured using a Jamar dynamometer (Kit Baseline, Arex, France), and three successive measurements were recorded for each hand. The maximum value was retained.
Functional Evaluation
Two self-administered questionnaires were used for noting functional evaluation scores from 0 to 100: the short version of the Disability of Arm Shoulder and Hand (QuickDASH) and the Patient-Rated Wrist Evaluation (PRWE). Pain was assessed by taking the PRWE pain score divided by 5 for getting a score ranging from 0 (no pain) to 10 (maximum pain).
Radiological Measurements
Anteroposterior and lateral views of the wrist showing the metacarpal head were taken before surgery and during the follow-up period and were inspected for:
Carpal sagittal subluxation measured on a lateral radiograph by the relation D / L 1, where D is distance between the axis of the radius and the axis of the third metacarpal and L 1 is the length of the third metacarpal. 13
Radial deviation of the carpus measured by Shapiro's angle. 14
Height of the carpus measured by the index of McMurtry et al. 15 This index also allowed us to assess subsidence of the implant in the midcarpal. We hypothesized that a decrease during postoperative follow-up would be linked to the subsidence in the midcarpal.
Ulnar carpal translation, measured by the index of Youm et al. 16
Height of the radial epiphysis, measured in millimeters by the distance of two parallel lines orthogonal to the axis of the radius, one at the proximal part of the ulnar notch of the radius and the other passing through the distal pole of the implant ( Fig. 1 ). Subsidence in the radius is defined as change in height over time.
Fig. 1.
Height of the radial epiphysis. a = distance between two lines perpendicular to the axis of the radius ( dotted line ), one passing through the proximal part of the ulnar notch of the radius and the other through the distal pole of the implant.
We also looked for the presence of lysis around the implant and geodes as well as malposition of the implants.
All per- and postoperative complications were collected.
The main outcome measurement was the degree of satisfaction. The secondary outcomes were functional, clinical, and radiological results.
Statistical Analysis
Quantitative data are expressed as mean ± standard deviation, with the minimum and maximum in brackets. Qualitative data are expressed as frequency. The paired Student's t -test, the Wilcoxon test, and Pearson's correlation coefficient were used for data analysis. A p -value < 0.05 was considered statistically significant.
The survival analysis was done according to the Kaplan–Meier method, with the main event being surgical revision. Patients lost to follow-up were censored to the right. The latest follow-up examination was used for them.
Data collection and statistical analysis were done with IBM SPSS Statistics version 25.
Results
Population
Our series included 87 implantations in 81 patients, 56.8% of them were males, with an average age of 58 years (25–84). Among the 81 patients, 59 were reviewed with a minimum of 5 years of follow-up, 4 died, and 18 (22%) could not be reviewed after 5 years and were considered lost to follow-up. The clinical and radiological analyses were performed on 59 patients (63 procedures) with a mean follow-up of 7.0 ± 1.5 years (5–11). Comparison of data at 2 years and at the last follow-up was also performed on these same patients.
We did not find any significant difference between the patient characteristics of those lost follow-up and the overall population of our study. Seventeen of the 18 patients lived far from our center. All patients lost to follow-up were unreachable because they did not respond to messages by phone or e-mail despite several unsuccessful follow-up visit reminders by mail. Table 1 shows the characteristics of the population and Table 2 summarizes the etiologies of the different cases dominated by Scapholunate advanced collapse (SLAC) lesions.
Table 1. Population characteristics.
| Sex | Male | 46 (57%) |
|---|---|---|
| Female | 35 (43%) | |
| Mean age (y) | 58 (25–84) | |
| Side | Right | 51 (59%) |
| Left | 36 (41%) | |
| Dominant side | 69 (85%) | |
| Previous surgery | 43 (49%) | |
| Professional activity | Sedentary | 21 (26%) |
| Manual | 31 (38%) | |
| Retired | 29 (36%) | |
| Work accident | 8 (10%) |
Table 2. Etiologies.
| SLAC | SLAC III | 1 | 20 (23%) |
| SLAC IV | 19 | ||
| SNAC | SNAC III | 1 | 5 (6%) |
| SNAC IV | 4 | ||
| SCAC III | 1 | 1 (1%) | |
| Rheumatoid arthritis | 16 | 16 (18%) | |
| Kienböck's disease, Lichtman stage III–IV | 10 | 10 (11%) | |
| Articular malunion of the distal radius | 10 | 10 (11%) | |
| Failure of silicone implant with synovitis | 6 | 6 (7%) | |
| Septic arthritis | 3 | 3 (3%) | |
| Sequelae of perilunate injury | 3 | 3 (3%) | |
| Failure of partial wrist fusion | 4 bones | 6 | 10 (11%) |
| Lunocapitate | 1 | ||
| Radioulnar | 1 | ||
| Scaphocapitate | 1 | ||
| STT | 1 | ||
| Failure of proximal row carpectomy | 2 | 2 (2%) | |
| Failure of scaphoidectomy | 1 | 1 (1%) |
Abbreviations: SCAC, Scaphoid chondrocalcinosis advanced collapse; SLAC, Scapholunate advanced collapse; SNAC, Scaphoid nonunion advanced collapse; STT: scapho-trapezio-trapezoid.
Satisfaction
According to the survey, 90% were very satisfied or satisfied with the procedure, 6% were fairly satisfied, and 4% were unsatisfied (two patients). The dissatisfaction was caused by the persistence of pain for the first patient, operated for a Scaphoid chondrocalcinosis advanced collapse wrist. The second patient, treated for SLAC grade III, had a postoperative complex regional pain syndrome (CRPS) and was dissatisfied with a final limitation of its wrist ROM.
Clinical Results
Active mobility was preserved between the preoperative measurements and those taken at 2-year follow-up and at the last follow-up visit. The difference was 0.1° for flexion, 9° for extension, 2° for inclination, with a final ROM of 73° for flexion–extension and 31° for inclination. The outcomes are shown in detail in Tables 3 and 4 .
Table 3. Clinical and functional outcomes (preoperative vs. last follow-up).
| Preoperative, mean (min. to max.) | LFU (mean = 84.6 mo) | Difference | p | |
|---|---|---|---|---|
| Mobility | ||||
| Flexion (°) | 37 (10–85) | 37 (0–80) | 0 | NS |
| Extension (°) | 29 (−10 to 80) | 37 (20–80) | 9 | NS |
| Ulnar inclination (°) | 21 (5–80) | 21 (5–40) | 0 | NS |
| Radial inclination (°) | 10 (−10 to 30) | 11 (0–25) | 2 | NS |
| Grip strength (kg) | 12 (0–42) | 20 (6–49) | 7 | <0.05 |
| % Strength a | 52 (18–107) | 68 (24–150) | 16 | <0.05 |
| Function and pain | ||||
| QuickDASH/100 | 63 (30–93) | 34 (0–71) | 28 | <0.05 |
| PRWE/100 | 63 (28–94) | 27 (0–80) | 36 | <0.05 |
| Pain/10 | 7 (3–9) | 3 (0–7) | 4 | <0.05 |
Abbreviations: LFU, last follow-up, mean (minimum to maximum); NS, not significant.
Percentage of contralateral side.
Table 4. Clinical and functional outcomes at 2-year follow-up and at the last follow-up.
| 2-year follow-up, mean (min. to max.) | LFU (mean = 84.6 mo) | Difference | p | |
|---|---|---|---|---|
| Mobility | ||||
| Flexion (°) | 38 (0–70) | 37 (0–80) | 1 | NS |
| Extension (°) | 35 (15–65) | 37 (20–80) | 2 | NS |
| Ulnar inclination (°) | 22 (10–40) | 21 (5–40) | 1 | NS |
| Radial inclination (°) | 14 (0–20) | 11 (0–25) | 3 | <0.05 |
| Grip strength (kg) | 16 (1–37) | 20 (6–49) | 4 | <0.05 |
| % Strength a | 59 (16–107) | 68 (24–150) | 9 | <0.05 |
| Function and pain | ||||
| QuickDASH/100 | 37 (2–80) | 34 (0–70) | 3 | NS |
| PRWE/100 | 29 (1–83) | 27 (0–80) | 2 | NS |
| Pain/10 | 3 (0–8) | 3 (0–7) | 0 | NS |
Abbreviations: LFU, last follow-up, mean (minimum to maximum); NS, not significant; PRWE, Patient-Rated Wrist Evaluation; QuickDASH, the short version of the Disabilities of the Arm, Shoulder, and Hand.
Percentage of contralateral side.
Pain was significantly improved, with a gain of 4 points between preoperative and the last follow-up, and remained stable between 2-year follow-up and the last follow-up, with a gain of 1 point ( p = 0.089). Strength was also significantly improved, with a gain of 7 kg and 16% compared with the contralateral side between preoperative and the last follow-up, and a gain of 4 kg ( p < 0.05) between 2-year follow-up and the last follow-up.
Functional Results
Functional scores were significantly improved between preoperative and the last follow-up. The QuickDASH improved by 27 points and PRWE by 36 points. Scores remained stable between the 2-year follow-up and the last follow-up, with a gain of 3 points for QuickDASH ( p = 0.549) and 2 points for PRWE ( p = 0.552).
Radiological Assessment
The radiological assessment did not show significant instability of the carpus over time. There was no difference for carpal sagittal subluxation, carpus height, and ulnar translation. The difference was 5° for radial deviation. Implant subsidence in the radius indicated a difference of 0.2 mm of the index between postoperative and last follow-up measurements ( Table 5 ). The radiological results remained stable between the 2-year follow-up and the last follow-up with nonsignificant differences ( Table 6 ).
Table 5. Radiological outcomes (preoperative vs. last follow-up).
| Preoperative | LFU (mean = 84.6 mo) | Difference | p | |
|---|---|---|---|---|
| Palmar subluxation | 0.1 (0–10) | 0.1 (-1 to 0.2) | 0 | NS |
| Radial deviation | 114 (8–125) | 109 (80–130) | −5.1 | <0.05 |
| Carpal height | 0.4 (0.3–0.5) | 0.4 (0.1–0.5) | 0 | NS |
| Ulnar translation | 0.3 (0.2–22) | 0.3 (0.2–0.4) | 0 | NS |
| 1-month follow-up | LFU | |||
| Height of radial epiphysis | 21.1 (16–26) | 20.9 (16–26) | 0.2 | NS |
Abbreviations: LFU, last follow-up, mean (minimum to maximum); NS, not significant.
Table 6. Radiological outcomes (2-year follow-up vs. last follow-up).
| 2-year follow-up | LFU (mean = 84.6 mo) | Difference | p | |
|---|---|---|---|---|
| Palmar subluxation | 0.1 (0–0.3) | 0.1 (−1 to 0.2) | 0 | NS |
| Radial deviation | 110 (93–123) | 109 (80–130) | −1 | NS |
| Carpus height | 0.4 (0.3–0.5) | 0.4 (0–0.5) | 0 | NS |
| Ulnar translation | 0.3 (0.2–0.4) | 0.3 (0.2–0.4) | 0 | NS |
| Height of radial epiphysis | 20.8 (16–24) | 20.9 (16–26) | 0 | NS |
Abbreviations: LFU, last follow-up, mean (minimum to maximum); NS, not significant.
Complications
Ten patients (12% of 87 cases) underwent surgery: one (1%) for radiocarpal and ulnocarpal conflict, five (6%) for implant rotation, and 4 for implant dislocation (5%). All complications occurred postoperatively within the first 15 months. Seven of the nine revisions were done within the first 2 years after initiating the use of the implant in our department.
The outcomes of patients who underwent revision surgery did not differ from those of the rest of the study population in terms of ROM improvement, functional scores, pain relief, or strength recovery ( Table 7 ).
Table 7. Comparison of improvement in outcomes between patients with revision surgery versus patients without revision surgery.
| No revision ( n = 57) | Revision ( n = 6) | Difference | p | |
|---|---|---|---|---|
| Range of motion (°) | 8 (−55 to 55) | 13 (−34 to 40) | 5 | NS |
| QuickDASH | 28 (−11 to 73) | 19 (5–34) | 9 | NS |
| PRWE | 38 (−7 to 74) | 21 (14–30) | 16 | NS |
| Pain | 4 (0.2–8.6) | 2 (0.2–4) | 2 | NS |
| Grip strength (kg) | 7 (−2 to 28) | 9 (1–16) | 2 | NS |
Abbreviations: NS, not significant; PRWE, Patient-Rated Wrist Evaluation; QuickDASH, the short version of the Disabilities of the Arm, Shoulder, and Hand.
The patient with a medial and lateral conflict was reoperated to perform radial styloidectomy and triquetrum excision. The five cases of implant rotation were treated by changing the size of the implant for four of them and performing radial styloidectomy in one case. In one case, relocation of the implant was performed after releasing a cam effect. For the cases of implant dislocation, two underwent capsular reinforcement (one anterior and one posterior), and the other two had changing of implant size.
We reported two cases (2%) of CRPS. We did not find any complications such as infection or hematoma.
Survival
The cumulated 10-year survival rate, using any revision as the endpoint, was estimated at 89%. None of the cases reviewed required removal of the implant or conversion to TWA or TWF. Figure 2 shows the Kaplan–Meier survival plots.
Fig. 2.
Kaplan–Meier plot.
Discussion
Amandys implant arthroplasty has shown, in preliminary and short-term studies, that it was a valid alternative to TWA and TWF for advanced wrist destruction. 8 9 10 17 18 The present study confirmed this finding showing wrist motion preservation and significant pain relief, function improvement, and grip strength recovery over time. This confirmed the main hypothesis of our study. We also observed that between 2 and 7 years, pain relief, mobility, and functional scores continued to slightly improve with significant improvement of grip strength ( Table 4 ). Implant was well tolerated and radiological biometric measurements of the wrist remained stable. Furthermore the survival rate did not deteriorate at mid or long term.
Outcomes were comparable to those reported for TWA with the same minimal follow-up ( Table 8 ). 19 20 21 22 23 24 TWA studies found a gain of between 14 and 32 points for QuickDASH, 23 between 3/10 and 8/10 for pain, 23 25 and between 3 and 5 kg for grip strength, versus 27, 4/10, and 7 kg, respectively in our study.
Table 8. Outcomes of TWA in published series with a minimum follow-up of 5 years and the present study.
| Implant | Cases (no.) | FU (y) | DASH | PRWE | Pain | ROM F/E a (deg) | ROM R/U b (deg) | Strength (kg) c | Complications | Revision | Survival | Criteria d | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Present study | Amandys | 63 | 7 | 34 | 27 | 2.7 | 75 | 32 | 20 (68%) | 14.2% | 12% | 89% at 10 y | Revision |
| Boeckstyns et al (2013) 19 | ReMotion | 52 | 7 | 42 | NR | 2.7 | 60 | 28 | 15 (NR) | 10% | 10% | 90% at 9 y | Removal |
| Fischer et al (2020) 20 | ReMotion | 69 | 10 | NR | NR | NR | NR | NR | NR | NR | NR | 94% at 10 y | Revision |
| Matsui et al (2020) 21 (RA only) | UHMWPE | 20 | 6 | 36 | NR | 0 | 48 | NR | NR | 0% | 0% | NR | NR |
| Reigstad et al (2011) 22 | Motec | 8 | 8 | 10 | NR | 1.5 | 125 | 32 | 31 (72%) | NR | 38% | NR | NR |
| Reigstad et al (2017) 23 | Motec | 56 | 8 | 25 | 27 | 0.8 | 126 | NR | 24 (75%) | 34% | 14% | 86% at 10 y | Revision |
| Zijlker et al (2019) 24 | Universal II | 26 | 11 | 41 | 44 | NA | NR | NR | NR | NA | 42% | NR | NR |
Abbreviations; FU, follow-up; NR, nonreported; NA, not applicable; RA, rheumatoid arthritis; TWA, total wrist arthroplasty; UHMWPE, ultra-high-molecular-weight polyethylene.
ROM F/E: mean flexion–extension range of motion.
ROM R/U: mean ulnar to radial deviation range of motion.
Strength (% related to the contralateral side).
Survival criteria.
Honecker et al, 2 who reported a series of TWA with the same follow-up as our study, found improvement in mobility, but strength remained lower. Boeckstyns et al reported a comparable improvement in strength, but with no significant difference in mobility with TWA using ReMotion after a 6-year mean follow-up ( Table 8 ). 19
In our study, the radiological findings were stable. There were no bone deterioration at the contact of the implant and we did not report any significant implant subsidence or carpal migration. The subsidence of the implant into the radius changed slightly during the first 2 years, then stabilized. The subsidence was very negligible in absolute value ( Table 4 ). The height of the carpus was measured between the top of the implant and the capitometacarpal joint related to the height of the third metacarpal. This variation in height may reflect subsidence of the implant into the carpus. The height remained stable up to the last follow-up, indicating no subsidence of the implant into the carpus or carpal collapse. We have noted as limits to the measurement of subsidence, measurement accuracy on analog films but also how they are performed. A slight extension/flexion when taking X-rays changes this height. X-ray resolution was another limiting factor in the precision of this measurement.
With a minimum follow-up of 5 years, the survival rate of the Amandys seems comparable to that of TWA ( Table 8 ). 19 20 21 22 23 24 Sagerfors et al 26 reported, for a series of 219 TWAs with a 7-year mean follow-up, survival varying between 95 and 81% depending on the prosthesis model. The survival rate for Amandys was stable over time, with a Kaplan–Meier curve that stabilized at around 15 months ( Fig. 2 ), unlike TWA. Boeckstyns 27 reported in a systematic review of wrist arthroplasty a drop in survival rate to 83% at 10 years, confirmed by Honecker et al, 2 who reported a survival rate decreasing from 91.3% at 6 years to 69% at 10 years. The survival rate also varied in the TWA and TWF studies depending on the criterion studied for survival. The studies that chose “removal of the implant” as an endpoint had better survival rates, 28 29 whereas it decreased if the endpoint was “any surgical revision of the implant.” 2 22 25 Survival worsened if they chose “loosening of the implant.” 30 Fischer et al, 20 in a prospective cohort of 136 TWAs, found that with “revision” as the endpoint, the 10-year survival rate was between 84 and 94% depending on the prosthesis model, but only between 50 and 90% if including “nonrevised loose implants” as the endpoint.
The rate of 12% of revision in our study remained lower than some rates reported for TWF and TWA. 31 32 33 Herzberg et al 34 reported, in his series of TWA using ReMotion 6% of revision.
TWA and TWF complications worsened over time, unlike results with Amandys. Wagner et al, 32 in a retrospective review of 215 patients who underwent TWF with a plate and had a 6-year mean follow-up, found 19% of revisions and a survival rate of 76% at 5.8 years. Reigstad et al 35 also reported significant rates of TWF revisions after 11 years of follow-up (63%).
In our department, 77% (seven cases) of revision of the Amandys implant occurred during the first 2 years of its use. This significant rate of revision at the start of our experience might be linked to the learning curve needed for the correct placement of the implant and management of the capsule. The selection of patients in our series (well-aligned carpus in the lateral view) was perhaps different from the TWA series and could have caused bias in the comparison between Amandys and TWA.
Our review of all pyrocarbon interposition arthroplasty of the wrist and hand also found stable outcomes over time in the medium and long terms. 36
Another alternative for the treatment of advanced stages of wrist destruction is proximal row carpectomy with a resurfacing capitate pyrocarbon implant (RCPI). Most studies 37 38 39 40 reported very few cases with a limited follow-up. Few series 37 41 42 43 have reported interesting outcomes with this implant at mid- to long term. Giacalone et al 44 reported on a series of 35 RCPIs with a mean follow-up of 33 months, one complication requiring TWF and 16% asymptomatic progression of radial implant osteoarthritis. Ross et al 43 also reported on a series of 29 patients at 35 months of mean follow-up, one case of radiographic loosening and five revisions to TWF. Marcuzzi et al 45 showed, in a review of 74 patients at 5 years of mean follow-up, an improvement of pain by 7 points, DASH score by 48 points, and grip strength by 9.8 kg. They reported one surgical revision for late infection at 7 years postsurgery. However, they found 25 cases (34%) with poor anchoring of the implant without clinical expression. Mid-term outcomes reported by Marcuzzi et al are encouraging and seem comparable to ours. The subsidence rate of the implant is quite low. The concern is the ulnar deviation of the wrist reported in 26% of the cases with possible ulnar chronic pain. The revision rate of RCPI implant to TWF varies according the series from 0 to 17%. 43
The early and medium-term review of Amandys 8 9 36 showed that complications occurred in the first postoperative year and mainly involved the first implants. The type of complication is also similar to other Amandys reviews, such as early instability in cases of capsuloligamentous laxity or impingement in the case of incomplete preparation of bone surfaces. Capsuloligamentous laxity and cam effect are important elements to detect and assess during surgery for Amandys arthroplasty. Pierrart et al, 10 in a study of a series of 11 patients at 1-year of follow-up, also found the same causes of early failure.
Our study found no carpal misalignment because the operative indications were on the aligned wrist, especially in the anteroposterior axis. Special attention was given in case of significant preoperative dorsal intercalated segment instability, where anterior capsular dehiscence may be present. The technique preserves the triquetrum as well as the dorsal radiocarpal and dorsal intercarpal ligaments, which are important for the wrist stability. This may explain that we did not find any occurrence of radiographic wrist instability postoperatively and with the follow-up.
Revision of Amandys implant did not affect in our series the long-term outcomes ( Fig. 3 ). This revision consisted almost exclusively of removing bone for correction of a cam effect, reinforcing palmar or dorsal capsule, or changing the size of the implant. These secondary procedures did not affect the final results and no significant difference in final outcomes was found between the patients requiring surgical revision and the other patients ( Table 7 ). Berber et al, 33 in a systematic review of 214 revision procedures for TWA failure, found a temporary improvement in functional scores at 1 year, which deteriorated at 5 years with a high rate of re-revision regardless of the type of revision (21% after TWF and 35% after TWA).
Fig. 3.
A 38-year-old man at 9.5-year follow-up for his left wrist intervention for Kienböck's disease stage IV. ( A ) 1 month postoperative X-rays with implant rotational instability; ( B ) X-rays 1 month after revision; ( C ) X-rays at 9.5-year follow-up.
The present study does suffer from a fairly high rate of loss to follow-up, which can induce nonresponse bias. We did not find any significant difference between the characteristics of the patients lost to follow-up and those of the overall population in our study. Nevertheless, 22% lost to follow-up in our review looks acceptable according to Tang et al. 46
Conclusion
Interposition arthroplasty using an Amandys implant offers a valid alternative to TWA or TWF for treatment of advanced wrist destruction when the wrist is centered. Wrist motion is preserved and there is significant improvement in pain, functional scores, and strength, which were confirmed over time. Patients were highly satisfied with the intervention. Complications occurred early, but do not worsen over time and are likely related to the learning curve. These results need to be confirmed over a longer period of time.
Footnotes
Conflict of Interest P.B. has a conflict of interest (royalties and consultant fees) with Tornier-Wright-Medical. Y.T., C.M.-C., E.G., T.L., and Y.K. have no conflict of interest.
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