External Fixation Prior to Fasciectomy Leads to Substantial Improvement of Advanced Dupuytren’s PIP Contractures at Mean Follow-up 15 Months

Abstract

Background:

The Digit Widget is an external fixation device that can be used to reverse proximal interphalangeal joint (PIPJ) contractures in the hand. Our hypothesis is that usage of the Digit Widget prior to fasciectomy in patients with severe Dupuytren’s proximal interphalangeal (PIP) contractures will result in short-term improvement and maintenance of the PIPJ contracture after fasciectomy.

Methods:

Patients who underwent placement of the Digit Widget soft tissue distractor prior to fasciectomy for Dupuytren’s disease were identified between January 2015 and December 2018. Multiple fingers were considered separately. Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Pain Interference, and Depression scores were collected. Patients treated for contractures from etiologies other than Dupuytren’s were not included. Multiple linear regression was used to compare initial PIP contractures, PF scores, and final contractures.

Results:

There were 28 fingers in 24 patients with average age of 56 ± 12 (30.5-69.9) years. Initial mean PIPJ contracture was 81° (50°-120°), which had corrected to 23° at time of removal. Average time between application and fasciectomy was 58 (28-112) days. At final follow-up, average 449 (58-1641) days, the average contracture was 39° (0°-105°). Contracture immediately following fasciectomy was found to be strongly correlated with the contracture at final follow-up. There was no statistical relationship between final PROMIS PF scores and final change in contracture.

Conclusions:

Digit Widget external fixation is an effective treatment for the correction of advanced PIPJ contractures related to Dupuytren’s disease, with an average of 52% improvement in contracture at 15 months.

Introduction

Dupuytren’s disease of the hand is a connective tissue disease in which the palmar fascia overlying soft tissue structures become fibrotic and form thick bands that can lead to flexion contractures that can affect function. Severe contractures can hinder a patient’s ability to do simple tasks such as putting a hand in the pocket or placing a hand flat on a table. Satisfaction rates were high after corrective surgery, with improvements in multiple patient-reported outcome measures (PROMs). ¹ The current treatment for this condition is to treat the end result, or contracture, as there is no curative treatment for the disease. Contractures involving the proximal interphalangeal joint (PIPJ) are more challenging, in terms of obtaining full correction of the contracture and maintaining correction than those involving the metacarpophalangeal joints (MCPJs).

There has been renewed interest in mechanical therapies. In the early 1990s, a series of biomechanics papers from Britain and Italy looked at continuous extension as a possible treatment of Dupuytren’s disease.^2,3 Their conclusion was that continued tensile force on scar tissue stimulated remodeling of scar tissue to become softer and more pliable. They also discovered that, without removal of the disease tissue, recurrence of contracture was high. This was shown in subsequent studies on skeletal traction from Britain. ⁴

Treatment of more advanced PIPJ contractures is challenging, both in terms of obtaining and maintaining correction. There are 2 general approaches to advanced PIP contractures. Some surgeons advocate capsulotomy or capsulectomy, with release of the volar plate and collateral ligaments.^5,6 Others prefer an external fixation device as part of a staged procedure. The Digit Widget utilizes rubber bands to create skeletal extension through bone pins to stimulate elongation of contracted volar tissue. This is paired with excision of the diseased tissue after reversal of the flexion contracture. ⁷

In addition to clinical findings, such as contracture degree, Patient Reported Outcome Measurement Information System (PROMIS) is a National Institutes of Health–developed general set of PROMs that allows for evaluation of a patient’s overall health and functional status when the electronic versions of the questionnaires are used. In such cases, PROMIS uses item response theory as part of a computer adaptive test and has performed in a similar manner to many of the legacy upper extremity (UE) PROMs.^8,9 The PROMIS domains are designed to follow a normal distribution based on a general US population and produce a T score with a mean of 50 and an SD of 10. Higher PROMIS Physical Function (PF) and UE scores indicate improved functional status, whereas lower Pain Interference (PI) and Depression scores indicate less pain with activity and mental health distress. ¹⁰ The PROMIS is not disease-specific; however, previous studies have shown strong correlation for PROMIS domains and previously validated outcome measures for a variety of hand conditions, including Dupuytren’s disease.^11-13

In this study, we aimed to answer the following questions:

• Research Question 1: Does the use of preoperative external fixation with the Digit Widget allow for correction of the PIP contracture prior to surgery?

• Research Question 2: Does preoperative correction correlate with short-term outcomes following fasciectomy?

• Research Question 3: In the subset of patients with PROMIS scores, does correction of the contracture correlate with subjective functional outcomes as measured by PROMIS PF questionnaires?

Our null hypothesis is there would be no early improvement in PIP contracture measurements in patients treated with Digit Widget external fixation prior to fasciectomy and that there would be no change in postoperative outcomes, based on PROMIS scores.

Materials and Methods

This study is a retrospective chart review of consecutive patients who underwent placement of the Digit Widget (Hand Biomechanics Lab, Sacramento, California) soft tissue distractor prior to fasciectomy by 1 of 2 surgeons practicing at a single academic medical center. Participants were selected through a chart review using the Current Procedural Terminology (CPT) codes 20690 (application of a uniplanar external fixator), with subsequent code 26123 (fasciectomy, partial palmar release including PIPJ), from the months of January 2007 to May 2020, with review of records for confirmation of the external fixation for the PIP contracture and related to Dupuytren’s disease. The PIPJ contractures were measured with a goniometer and recorded as degrees of contracture from 0° at maximum extension. Major contractures were defined as greater than 60° of contracture. Because visit intervals were not consistent, each visit is referred to as visit numbers after each procedure. Treatment was in a staged manner, with placement of Digit Widget external fixation, followed by fasciectomy at an average of 8.35 ± 2.46 weeks following the Digit Widget placement. The majority of fixator applications were performed under local anesthetic only (12/20), with 7 patients requiring additional sedation, and 1 who required general anesthetic. For the following fasciectomy procedures, 11 out of 20 patients used local anesthetic with sedation, 8 patients used local anesthetic only, and 1 patient required general anesthesia. The Digit Widget was removed at the time of fasciectomy in all cases. Postoperatively, patients were started immediately with not only an active range of motion protocols but also given night splints for 2 weeks in intrinsic plus posture for wound healing. Formal hand therapy was assigned if patients experienced stiffness with range of motion, such as inability to make a composite fist, at the 4 weeks postoperative appointment.

The PROMIS PF, PI, and Depression data were collected for visits beginning after 2015 as part of routine clinical care, on an iPad (Apple, Cupertino, California). Range of motion was measured at various time points during the patient’s treatment course: preoperative visit, prior to Digit Widget placement, prior to fasciectomy, immediate postoperative, and final postoperative scores. Complications include infection (with or without prescription of antibiotics), postsurgical deformity, fracture, nerve injury, repeat surgery, or progression to amputation.

Inclusion Criteria

Participants were selected through a chart review using the CPT code 20690 (application of an external fixator), with subsequent code 26123 (fasciectomy, partial palmar release) from the months of January 2007 to May 2020 with an isolated diagnosis of Dupuytren’s disease. Multiple fingers were considered separate if each finger met inclusion criteria.

Exclusion Criteria

Patients with contractures attributed to any other diagnosis other than Dupuytren’s disease, such as posttraumatic or previous surgeries without the diagnosis of Dupuytren’s disease, were excluded.

Statistical Analysis

Multiple linear regression analysis was used to determine the relationship of final contracture to patient factors, preoperative contracture, and post operative contracture after Digit Widget placement and fasciectomy (physical therapy [PT] vs injection vs surgery). In addition, Pearson correlation analysis was used to compare contractures at various time points. Statistical significance for all tests was set at P < .05.

Results

A total of 24 patients (16 men and 8 women—mean age of 56 ± 12 years) with 28 fingers were included in the final analysis (Table 1). The most common affected finger was the small finger (60.7%) followed by the ring finger (28.6%) and the middle finger (10.7%). Most deformities were left-sided (67.9%), with 13/28 (46.4%) on the dominant side. Initial average MCPJ contracture was 37° ± 33.8°; however, the final MCPJ contracture records were incomplete. The initial average PIPJ preoperative contracture was 80.9° ± 15.3°, which was corrected to 23.0° ± 17.5° at time of fasciectomy and 38.7° ± 4.86° at final follow-up, representing an improvement of 42° or 52%. In effect, 17/28 fingers achieved a final PIPJ contracture of 40° or less. The mean time between surgeries was 58 ± 17 days, with average time to final follow-up at 15 ± 2.1 months (Table 2).

Table 1.

Demographics and Characteristics of Patients.

Demographics	Major (>60) (n = 24)	Minor (≤60) (n = 4)	Total (n = 28)
Sex
Female	8 (33.3%)	1 (25%)	9 (32.1%)
Male	16 (66.7%)	3 (75%)	19 (67.9%)
Age, y
Mean (SD)	54.4 (12.1)	66.2 (3.53)	56.0 (12.0)
Median [minimum, maximum]	58.0 [30.5, 66.5]	66.9 [61.4, 69.9]	59.6 [30.5, 69.9]
Handedness
Left	4 (16.7%)	0 (0%)	4 (14.3%)
Right	20 (83.3%)	4 (100%)	24 (85.7%)
Laterality
Left	17 (70.8%)	2 (50.0%)	19 (67.9%)
Right	7 (29.2%)	2 (50.0%)	9 (32.1%)
Finger
Middle	1 (4.2%)	2 (50.0%)	3 (10.7%)
Ring	8 (33.3%)	0 (0%)	8 (28.6%)
Small	15 (62.5%)	2 (50.0%)	17 (60.7%)
Race
Black	1 (4.2%)	0 (0%)	1 (3.6%)
White	23 (95.8%)	4 (100%)	27 (96.4%)

Note. The demographics and patient characteristics included in this study are shown. Major contractures are PIPJ contractures found to be greater than 60°. Minor contractures are those 60° or less. PIPJ = proximal interphalangeal joint.

Table 2.

Average and Median Values of PIPJ Contracture Throughout the Treatment Pathway.

Joint characteristics	Major (>60) (n = 24)	Minor (≤60) (n = 4)	Total (n = 28)
Initial PIPJ contracture
Mean (SD)	85.2 (13.2)	55.0 (5.77)	80.9 (16.4)
Median [min, max]	85.0 [65.0, 120]	55.0 [50.0, 60.0]	80.0 [50.0, 120]
Contracture prior to fasciectomy
Mean (SD)	23.8 (18.6)	15.5 (6.66)	22.6 (17.6)
Median [min, max]	25.0 [0.00, 65.0]	13.5 [10.0, 25.0]	22.5 [0.00, 65.0]
Contracture after fasciectomy (within 14 days postoperative)
Mean (SD)	23.5 (20.8)	21.3 (10.3)	23.2 (19.5)
Median [min, max]	22.5 [0.00, 70.0]	22.5 [10.0, 30.0]	22.5 [0.00, 70.0]
Time between surgeries (days)
Mean (SD)	59.2 (17.8)	54.3 (14.7)	58.5 (17.3)
Median [min, max]	59.5 [28.0, 112]	55.0 [37.0, 70.0]	59.0 [28.0, 112]
Final contracture
Mean (SD)	39.7 (27.1)	33.0 (16.8)	38.7 (25.7)
Median [min, max]	40.0 [0.00, 105]	31.0 [15.0, 55.0]	37.5 [0.00, 105]

Note. The starting PIPJ contractures, contractures as measured prior to and after DW removal, and final contractures are shown. Also included is the time between Digit Widget placement and removal with fasciectomy. PIPJ = proximal interphalangeal joint.

Figure 1 shows the progression of all 28 fingers through treatment. Patients with increased degree of contracture immediate postoperative after fasciectomy were found to have statistically significantly higher degrees of contracture at final follow-up (P = .007; Figure 2). Patients who saw smaller corrections with the Digit Widget on also had larger residual contracture prior to fasciotomies. Interestingly, the degree of contracture right before fasciotomy was not found to be correlated to final contracture. Right-sided pathology and increasing age were found to have significantly lower degrees of contracture at final follow-up. Patients with multiple fingers involved (mean = 0.7) were more likely to have recurrent contractures compared with single digits (0.22; P < .03). Patients with higher initial PROMIS PF scores experienced a greater decrease in their contracture, but this was not statistically significant (P = .08; Figure 3).

Figure 1.

The progression of all 28 fingers from initial visit to final visit is shown.

Note. Exact time points were variable, so each visit was referenced as a visit from operative procedure and converted to a time point relative to the initial visit. The leftmost black bar represents placement of the fixator and the right black bar represents the removal of the fixator with fasciectomy. All patients had a fixator placed immediately after their initial visit, and by the sixth visit, all patients had their fixator off and fasciectomy done. The solid thick red line represents the average contracture at each time point.

Figure 2.

A strong correlation of final contracture with contracture immediately after fasciectomy is shown.

Note. Patients with greater contractures after removal of the Digit Widget were found to have greater contractures at final follow-up.

Figure 3.

A mild correlation between the initial PROMIS Physical Function scores and amount of contracture correction at final follow-up is shown.

Note. PROMIS = Patient Reported Outcome Measurement Information System.

Two patients ended with contractures worse than their initial contractures (prior to Digit Widget application) at final follow-up. The first quartile for contracture change went from 5° to −20°. Complications included 3 pin site infections receiving antibiotics (Keflex), 1 patient with pin site numbness that improved, and 1 nondisplaced pin site fracture. Two patients developed boutonniere’s deformity after fasciectomy. One patient desired an amputation, despite a 40° improvement of contracture.

Discussion

Use of distraction and extension torque instrumentation as an adjunct treatment of Dupuytren’s disease is not widespread but early results have been encouraging. This study aims to look at the use of a commercial external fixation device prior to fasciectomy in the treatment of advanced Dupuytren’s disease PIPJ contractures. We found that this technique was effective at providing a notable improvement of an average of 42° of deformity correction. The maximum improvement of the PIPJ contracture was seen at the time of the second surgery prior to removal of the Digit Widget, with some degree of recurrence after removal and fasciectomy. Initial contracture was not predictive of the degree of final contracture, but degree of contracture post-fasciectomy was. The combined effect of use of the external fixator and fasciectomy is necessary for sustained correction. This, in conjunction with the large degree of correction that the Digit Widget provides, could represent an approach to tackling cases of advanced Duyputren’s disease by using the Digit Widget to perform the major correction gradually, followed by fasciectomy to remove the Dupuytren’s tissue. However, patients who saw a smaller degree of improvement with the Digit Widget also had greater residual contracture at the time of fasciectomy. Although we did not find that degree of contracture prior to fasciectomy to be correlated to final contracture, this suggests that there exists a patient population who may not respond as well to manual traction.

Our results are similar to previously published literature looking at this technique. Cahill et al looked at an external fixation technique that they called the pins and rubber band technique. In their case series of 7 patients, they saw an improvement from a mean preoperative contracture of 82.7° to a postoperative contracture of 22.8°. Four patients required regional fasciectomies after device removal. ¹⁴

White et al ¹⁵ described a similar technique with improvement from 75° to 37° but found a 30% “significant relapse” rate at average mean follow-up at 20.6 months, although it is unclear what that means. In our study, 16/28 or 57% of patients saw a recurrence of at least 20°.

Craft et al compared the Digit Widget with fasciectomy with checkrein ligament release and found digits treated with distraction had more extension improvement (53.4°-31.4°, P < .001). This remained true for both minor (<60°) and major (>60°) contractures at a mean follow-up of 18 (3-24) months. However, they found that use of the Digit Widget was not associated with any recurrence of contractures. This result may be caused by short-term follow-up. In addition, 10 out of 17 digits were reoperations. ¹⁶

A study by Weinzweig et al looked at fasciectomy and capsulotomy versus fasciectomy alone in severe PIPJ contractures in the setting of Dupuytren’s disease. In their study, their postoperative contractures were similar between the 2 groups, with contractures of 78.4° and 82.5° preoperatively and with correction to 36.6° and 36.8° postoperatively, which are similar to our final follow-up contractures with the Digit Widget. ¹⁷ With the Digit Widget, we were able to achieve better correction with it on, but were unable to maintain this correction.

Our study has several limitations. It is a retrospective study and contracture measurements are not precise. Some patients had involvement of MCPJs and PIPJs, whereas others had isolated PIPJ involvement, and some had multiple digits, whereas others had a single digit. There is also a varying degree of contracture in the joints where the Digit Widget was used. Although this makes interpretation of the data more complex, it is representative of the condition. Our follow-up is limited and, given the reported risk of recurrent contracture, long-term follow-up is necessary to determine whether the early correction of the contracture is maintained and the development of recurrent disease. In addition, it can be difficult to determine the cause of the PIP contracture and whether there is an intrinsic joint contracture along with the Dupuytren’s contracture and thus, it is possible these patients could have had the same result with fasciectomy alone or fasciectomy and open PIPJ release. Ideally, we would have a control group during this time with similar contractures treated solely with fasciectomy to compare the effectiveness of the use of the Digit Widget. We began collecting PROMIS scores in 2015, so not all patients had subjective outcomes to go along with the objective measurements.

This study demonstrates that use of a 2-stage procedure is effective in the treatment of advanced Dupuytren’s disease and that post-fasciectomy correction was the most important indicator for final contracture correction.