Abstract
Background
The use of rehabilitative knee braces after anterior cruciate ligament reconstruction (ACLR) has been controversial. This study aimed to evaluate the early functional outcome associated with post-ACLR brace use.
Methods
This prospective observational case–control study was conducted at AKB Center for Arthroscopy, Sports Injury, and Regenerative Medicine, B&B Hospital, Lalitpur, Nepal. A total of 132 patients undergoing arthroscopic ACLR with or without a meniscal procedure were enrolled in this study, with the final analysis consisting of 66 patients in the control group (brace group) and 66 patients in the case group (no brace group). Braces were applied to the affected lower limb in the control group in the operating room immediately after surgery and were continued for 4 weeks post-operatively. The rehabilitation protocol was the same for both groups. The patients were evaluated on the 3rd post-operative day, 2 weeks, 6 weeks, and 12 weeks post-operatively in terms of Lysholm knee scores, clinical tests (Lachman and pivot shift test), range of motion (flexion and extension), VAS scores for pain, thigh girth differences, and the 12-item short-form health survey (SF-12) scores.
Results
There were no significant differences between the two groups regarding outcome measures, except the mental component summary of SF-12 which was significantly better in the non-braced group (P = 0.006).
Conclusion
There was no significant difference in early functional outcome between the braced and non-braced groups following ACLR with or without a meniscal procedure. Better SF-12 mental component summary scores were seen in the nonbraced group, which indicated possible mental discomfort in patients with brace use.
Keywords: Anterior cruciate ligament reconstruction, Functional outcome, Knee brace, Rehabilitative brace
Introduction
Anterior cruciate ligament (ACL) tears are common injuries, especially in young adults with an incidence rate of around 68.6 per 100,000 person-years, resulting in up to 200,000 ACL injuries occurring annually in the United States alone [1, 2]. Likewise, experts estimate that there are approximately two million ACL injuries that occur globally each year [3]. There is an increasing trend of ACL reconstruction (ACLR) in managing these injuries with around 60% to 75% of individuals with ACL injuries undergoing ACLR [2, 4–6].
The post-operative rehabilitation protocol plays a vital role in the functional outcome after surgery [7]. Bracing after ACLR has usually been considered an integral part of rehabilitation; nevertheless, the benefit of its use has been debated [8]. A rehabilitative brace is believed to protect the healing graft from increased loads secondary to quadriceps and hamstring weakness in the early post-operative period while allowing early knee motion [9]. It has also been advocated to protect against sudden flexion of the quadriceps during weight-bearing post-surgery [10]. Additionally, studies have reported that braces improve knee proprioception after ACLR [11]. However, the routine use of a brace may lead to muscle inhibition and thigh atrophy, which, conversely, may place a higher load on the graft [12, 13]. Other studies have also shown that a brace may be protective only against minor anteroposterior translational forces and sub-physiological rotation movements of the knee but not against unexpected movements; thus, the absence of brace use may not be a cause of graft failure in the early post-operative period [14].
In clinical practice, the use of rehabilitative braces following ACLR has been controversial. Multiple studies have shown no difference in long-term functional outcomes between the brace and no brace groups after ACLR [8, 13–19]. However, limited studies have compared the early functional outcome associated with post-ACLR brace use. Likewise, there is a paucity of such studies that have been conducted in our population. At our institute, we routinely use braces as part of post-ACLR rehabilitation. So, through this study, we aimed to understand if such use of braces was useful or not and the results thus obtained could directly influence our clinical practice.
Materials and Methods
This prospective observational case–control study was conducted at the AKB Center for Arthroscopy, Sports Injury, and Regenerative Medicine, B&B Hospital, Lalitpur, Nepal over a period of 15 months (September 2022–November 2023). All patients of age ≥ 18 years undergoing arthroscopic ACLR only, or arthroscopic ACLR with a meniscal procedure (either partial meniscectomy or meniscal repair), were included in this study. Informed written consent was obtained from all the participants. Patients with multi-ligament knee injuries, those undergoing arthroscopic ACL repair, patients with a history of fractures or surgery to the same knee, those with knee osteoarthritis of Grade 3 or higher (Kellgren–Lawrence classification system), patients undergoing ACLR with any other procedure that delayed weight-bearing and ambulation (such as high tibial osteotomy and osteochondral fracture fixation), patients undergoing ACLR with lateral extra-articular tenodesis or anterolateral ligament reconstruction, and those with contralateral lower limb pathology were excluded.
Based on the study of Mayr et al. [16], using the standard formula, the sample size was calculated to be 132, with 66 patients in each group. The demographic profile, mode of injury, time from injury to surgery, and other pre-operative variables were recorded in the pro forma.
Surgery
All routine blood investigations, an X-ray, and an MRI of the involved knee were done. The standard arthroscopic anatomic transportal single bundle ACLR was performed by one of four arthroscopic surgeons (the senior surgeon with more than 15 years of experience, two surgeons with more than 5 years of experience, and one surgeon with more than 3 years of experience in arthroscopic knee surgeries) at the institute. The surgery was performed under spinal or general anesthesia, and a pneumatic tourniquet was applied to the upper thigh and inflated. The appropriate autograft [Semitendinosus (SemiT) with or without Gracilis, Bone-Patellar Tendon-Bone (BPTB), Peroneus Longus (PL), or Superficial Quadriceps] was harvested from the same limb. The graft was folded and refolded to achieve a minimum diameter of 8 mm. Remnant preservation was done whenever feasible. For soft tissue grafts, the femoral fixation was done with a suspensory fixation device (ONButton CL® Fixation Button or BUTTONFIX® Fixation Button with Adjustable Loop, Biotek, Gujarat, India), and the tibial fixation was done with an interference screw (BIOTWIN™ Composite Interference Screw, Biotek, Gujarat, India). While for the BPTB graft, both femoral and tibial fixation were done with an interference screw (SOFTFIX-PK® Interference screw, Biotek, Gujarat, India).
Randomization and Group Allocation
The patients were randomly divided, with a 1:1 allocation using block randomization (block sizes of 2, 4, and 6) in a Microsoft Excel Sheet, into two groups: the control group was prescribed a post-operative brace and the case group underwent routine post-operative rehabilitation without a brace. The brace was a hinged range of motion (ROM) knee brace: Dyna limited motion knee brace (Dynamic Techno Medicals, Kerala, India) (Fig. 1). After the surgery was completed, based on the randomization list, the patient was assigned to either the case or the control group. Immediately after skin closure and dressing, the brace was applied to the affected lower limb in the control group in the operating room.
Fig. 1.
Dyna limited motion knee brace in extension and flexion
Rehabilitation
The rehabilitation protocol was the same for both groups. In the control group, the brace was worn day and night for 4 weeks post-operatively and was taken off only during physiotherapy. The brace was locked in extension while the patient was on the bed and was set at 0–60 degrees while walking for the first 2 weeks (week 1 to week 2) post-operatively. While sitting, it was set at 0–90 degrees. Thereafter, it was unlocked to 90 degrees for the next 2 weeks (week 3 to week 4) after which the brace was discontinued. Both groups were given crutch mobilization and weight-bearing as tolerated from the first post-operative day for ACLR with or without partial meniscectomy, and the crutches were discontinued after full knee extension was restored and there was no residual flexion deficit. In patients who underwent ACLR with meniscal repair, weight-bearing was started after 6 weeks post-operatively. The patients were discharged from the hospital after attaining 90-degree active knee ROM. Supervised physiotherapy was continued after discharge from the hospital. The first follow-up visit was on the 14th post-operative day when suture removal was done. Thereafter, follow-up visits were at 6 weeks and 12 weeks, respectively.
Outcome Measures
Knee function was assessed using the Lysholm knee scoring scale [20] and clinical tests (Lachman test and Pivot shift test), pre-operatively and at 12 weeks of follow-up. With the patient in the supine position, a long-armed goniometer was used to measure the passive knee ROM (flexion and extension), immediately before surgery, and then at 2 weeks, 6 weeks, and 12 weeks post-operatively, respectively (Fig. 2). The neutral position was taken as 0 degrees, and the flexion ROM was recorded in the positive range (e.g., 0 to 140 degrees). On the other hand, the extension was recorded in the negative range (e.g., 0 to − 10 degrees), thus signifying hyperextension. The Visual analog scale (VAS) graded from 0 (no pain) to 10 (worst pain imaginable) was used to evaluate the subjective experience of pain immediately before surgery, on the 3rd post-operative day, at 2 weeks, 6 weeks, and 12 weeks post-operatively. The thigh girth differences between the measurement at the final follow-up with the contralateral lower limb as well as with the ipsilateral pre-operative measurement were recorded. The thigh girth measurement was taken 15 cm proximal to the patella's superior pole (Fig. 3). Patient satisfaction regarding brace use or no brace use was recorded via the 12-item short-form health survey (SF-12) [21] for both groups at 6 weeks of follow-up. Complications, if any, were recorded.
Fig. 2.
Knee ROM measurement A flexion and B extension
Fig. 3.
Thigh girth measurement
Statistical Analysis
The data collected were recorded in the pro forma and entered in Microsoft Excel 2019. A statistical software program (IBM SPSS Statistics for Windows, v23.0; IBM Corp) was used to perform data analysis. Appropriate parametric and nonparametric tests were used to evaluate the data. The outcomes at various follow-up intervals were compared, and both the magnitude and significance of the difference were measured using appropriate statistical tools.
Results
A total of 132 patients, fulfilling the inclusion criteria, were enrolled in this study, with the final analysis consisting of 66 patients in the control group and 66 patients in the case group. There was no significant difference in the pre-operative demographic variables and operative variables in both groups (Table 1). In both the groups, ACLR with meniscal repair was the most commonly performed operative procedure [38 patients (57.6%) in each group], followed by isolated ACLR [19 patients (28.8%) in the control group and 22 patients (33.3%) in the case group], and the addition of meniscal procedures had no significant impact in both the groups (Table 1).
Table 1.
Pre-operative demographic variables and operative variables
| Parameters | Group | P value | ||
|---|---|---|---|---|
| Control group (n = 66) | Case group (n = 66) | |||
| Gender distribution | Male | 50 | 55 | 0.281* |
| Female | 16 | 11 | ||
| Age in years | Mean ± SD | 28.92 ± 8.81 | 29.26 ± 9.67 | 0.971a |
| Median (IQR) | 26.5 (22.0–35.0) | 26.5 (22.0–34.0) | ||
| Mode of injury | RTA | 11 | 15 | 0.672* |
| Sports | 38 | 36 | ||
| Non-contact | 17 | 15 | ||
| Time from injury to surgery in days | Mean ± SD | 432.11 ± 669.62 | 329.29 ± 719.64 | 0.172a |
| Median (IQR) | 165 (28.5–730) | 60 (27.3–293.8) | ||
| Side of injury | Right | 34 | 44 | 0.077* |
| Left | 32 | 22 | ||
| Side dominance | Right | 65 | 66 | NA |
| Left | 1 | 0 | ||
| Height in cm | Mean ± SD | 166.95 ± 7.64 | 167.48 ± 6.96 | 0.678a |
| Median (IQR) | 167.0 (162.0–171.3) | 167.0 (164.5–172.0) | ||
| Weight in kg | Mean ± SD | 70.56 ± 9.25 | 69.48 ± 10.05 | 0.523a |
| Median (IQR) | 70 (65–75) | 70 (62–75) | ||
| BMI | Mean ± SD | 25.37 ± 3.14 | 24.69 ± 3.20 | 0.219a |
| Median (IQR) | 24.5 (22.9–27.7) | 24.5 (22.8–26.6) | ||
| Surgical procedure | ACLR | 19 | 22 | 0.664* |
| ACLR with partial meniscectomy | 9 | 6 | ||
| ACLR with meniscal repair | 38 | 38 | ||
| Graft used | SemiT | 11 | 15 | 0.342* |
| SemiT + Gracilis | 34 | 39 | ||
| Peroneus longus | 12 | 6 | ||
| BPTB | 8 | 5 | ||
| Superficial quads | 0 | 1 | ||
| PL + Gracilis | 1 | 0 | ||
*Chi-square test; aMann–Whitney U test; NA: Not Applicable due to inadequate cell values; P < 0.05 signifies statistical significance
There was no significant difference in the Lysholm knee scores between the two groups. Post hoc pairwise comparison showed a statistically significant increase in Lysholm scores between pre-operative assessment and 12 weeks post-operative assessment. The majority of the patients (95.5% in the control group and 89.4% in the case group) demonstrated Grade 3 laxity during the Lachman test pre-operatively. Similarly, most of the patients (69.7% in the control group and 68.2% in the case group) had Grade 1 pivot shift instability on pre-operative clinical examination. All the patients had a negative Lachman test and no pivot shift instability at the final follow-up visit in both groups (Table 2).
Table 2.
Knee function assessment
| Control group (n = 66) | Case group (n = 66) | P value | |||
|---|---|---|---|---|---|
| Lysholm knee score | Pre-operative | Mean ± SD | 59.70 ± 18.93 | 59.38 ± 17.73 | 0.790a |
| Median (IQR) | 61.5 (49–75.3) | 62 (46–71) | |||
| 12 weeks | Mean ± SD | 93.88 ± 6.06 | 95.00 ± 5.15 | 0.195a | |
| Median (IQR) | 95 (90–99) | 96.5 (91–99) | |||
| P value | < 0.001b | < 0.001b | |||
| Lachman test | Pre-operative | Grade 2 | 3 | 7 | 0.188* |
| Grade 3 | 63 | 59 | |||
| 12 weeks | Negative | 66 | 66 | NA | |
| Pivot shift test | Pre-operative | Absent | 2 | 3 | 0.799* |
| Grade 1 | 46 | 45 | |||
| Grade 2 | 14 | 16 | |||
| Grade 3 | 4 | 2 | |||
| 12 weeks | Negative | 66 | 66 | NA | |
*Chi-square test; aMann–Whiney U test; bWilcoxon Signed Rank test; NA: Not Applicable due to inadequate cell values; P < 0.05 signifies statistical significance
There were no significant differences in the ROM (flexion and extension) between the two groups. Post hoc pairwise comparison showed a statistically significant increase in flexion ROM at each assessment except between pre-operative assessment and 2 weeks post-operative assessment. Likewise, post hoc pairwise comparison showed a statistically significant decrease in extension ROM (thus, signifying improving hyperextension) at each assessment except between pre-operative assessment and 2 weeks post-operative assessment (Table 3).
Table 3.
ROM measurement values
| Control group (n = 66) | Case group (n = 66) | P value | |||
|---|---|---|---|---|---|
| Flexion ROM | Pre-operative | Mean ± SD | 137.42 ± 3.95 | 137.65 ± 3.64 | 0.811a |
| Median (IQR) | 140 (135–140) | 140 (135–140) | |||
| 2 weeks | Mean ± SD | 100.76 ± 9.97 | 102.50 ± 10.46 | 0.255a | |
| Median (IQR) | 100 (90–100) | 100 (100–110) | |||
| 6 weeks | Mean ± SD | 125.38 ± 9.34 | 128.18 ± 7.32 | 0.087a | |
| Median (IQR) | 125 (120–130) | 130 (120–135) | |||
| 12 weeks | Mean ± SD | 137.05 ± 3.51 | 137.73 ± 3.18 | 0.254a | |
| Median (IQR) | 140 (135–140) | 140 (135–140) | |||
| Extension ROM | Pre-operative | Mean ± SD | − 6.82 ± 5.16 | − 5.68 ± 5.61 | 0.126a |
| Median (IQR) | − 10 (− 10 to − 5) | − 5 (− 10 to 0) | |||
| 2 weeks | Mean ± SD | − 1.44 ± 4.09 | − 1.59 ± 4.03 | 0.611a | |
| Median (IQR) | 0 (− 5 to 0) | 0 (− 5 to 0) | |||
| 6 weeks | Mean ± SD | − 5.00 ± 3.92 | − 5.45 ± 4.70 | 0.199a | |
| Median (IQR) | − 5 (− 5 to − 5) | − 5 (− 10 to − 5) | |||
| 12 weeks | Mean ± SD | − 8.56 ± 3.01 | − 7.50 ± 3.64 | 0.116a | |
| Median (IQR) | − 10 (− 10 to − 5) | − 10 (− 10 to − 5) | |||
| P value | < 0.001b | < 0.001b | |||
aMann–Whiney U test; bFriedman test; P < 0.05 signifies statistical significance
There was no significant difference in the VAS scores for pain between the two groups. Post hoc pairwise comparison showed a statistically significant decrease in VAS scores at each assessment except between pre-operative assessment and 3rd post-operative day assessment (Table 4).
Table 4.
VAS scores for pain comparison
| Control group (n = 66) | Case group (n = 66) | P value | |||
|---|---|---|---|---|---|
| VAS score | Pre-operative | Mean ± SD | 2.39 ± 0.94 | 2.45 ± 1.01 | 0.990a |
| Median (IQR) | 2 (2–3) | 2 (2–3) | |||
| 3rd post-operative day | Mean ± SD | 2.31 ± 0.68 | 2.17 ± 0.48 | 0.304a | |
| Median (IQR) | 2 (2–3) | 2 (2–2.1) | |||
| 2 weeks | Mean ± SD | 1.76 ± 0.47 | 1.70 ± 0.50 | 0.581a | |
| Median (IQR) | 2 (1–2) | 2 (1–2) | |||
| 6 weeks | Mean ± SD | 1.23 ± 0.46 | 1.14 ± 0.43 | 0.241a | |
| Median (IQR) | 1 (1–1.3) | 1 (1–1) | |||
| 12 weeks | Mean ± SD | 0.59 ± 0.53 | 0.56 ± 0.56 | 0.682a | |
| Median (IQR) | 1 (0–1) | 1 (0–1) | |||
| P value | < 0.001b | < 0.001b | |||
aMann–Whiney U test; bFriedman test; P < 0.05 signifies statistical significance
There was no significant difference in the thigh girth differences at the final follow-up between the two groups. Regarding satisfaction scores (SF-12), there was no significant difference in the physical component summary (PCS-12) scores between the two groups. However, the mental component summary (MCS-12) scores were significantly higher in the case group than in the control group (P value 0.006) (Table 5).
Table 5.
Other outcome variables
| Outcomes | Group | P value | |||
|---|---|---|---|---|---|
| Control group (n = 66) | Case group (n = 66) | ||||
| Thigh girth difference at 12 weeks (with pre-operative ipsilateral thigh) | Mean ± SD | 0.58 ± 0.54 | 0.60 ± 0.56 | 0.818a | |
| Median (IQR) | 0.5 (0–1.0) | 0.5 (0–1.0) | |||
| Thigh girth difference at 12 weeks (with contralateral thigh) | Mean ± SD | 0.44 ± 0.85 | 0.36 ± 0.82 | 0.907a | |
| Median (IQR) | 0 (0–1) | 0.5 (0–1) | |||
| Satisfaction scores | PCS-12 | Mean ± SD | 48.53 ± 4.55 | 48.91 ± 4.05 | 0.616a |
| Median (IQR) | 49.5 (46.1–51.4) | 49.5 (47.8–50.9) | |||
| MCS-12 | Mean ± SD | 53.17 ± 4.79 | 55.22 ± 3.58 | 0.006a | |
| Median (IQR) | 54 (49–57) | 55.5 (52.6–57.1) | |||
aMann–Whitney U test; P < 0.05 signifies statistical significance
The majority of the patients (86.4% in both groups) did not have any post-operative complications. Two patients in both groups had superficial surgical site infection over the graft harvest site, which was treated with oral antibiotics and subsided by the next follow-up visit. Two patients in the case group and four patients in the control group complained of paresthesia over the hamstring harvest site, which persisted at the final follow-up. One patient in the case group complained of ankle pain at the peroneus longus graft harvest site. Four patients in the control group complained of abrasion or bruising associated with brace use, but they resolved spontaneously after brace discontinuation. One patient each in both the groups had limited ROM, i.e., they were unable to regain their normal pre-operative 10 degrees of hyperextension by 12 weeks follow-up. One patient in the case group had persistent knee effusion at the final follow-up visit (Table 6).
Table 6.
Complications
| Complications | Group | P value | |
|---|---|---|---|
| Control group (n = 66) | Case group (n = 66) | ||
| None | 57 | 57 | NA |
| Superficial surgical site infection | 2 | 2 | |
| Paresthesia over hamstring harvest site | 2 | 4 | |
| Ankle pain at PL graft harvest site | 0 | 1 | |
| Abrasion/ bruising due to brace | 4 | 0 | |
| Limited ROM (Extension loss) | 1 | 1 | |
| Persistent effusion | 0 | 1 | |
NA: not applicable due to inadequate cell values; P < 0.05 signifies statistical significance
Discussion
The major finding of our study was that there was no significant difference between the brace and no brace groups following ACLR with or without a meniscal procedure at 12 weeks follow-up in terms of the outcome measures except for the MCS-12 satisfaction scores, which were significantly higher in the non-braced group.
Post-operative bracing after ACLR is a relatively common practice among knee surgeons. This is because rehabilitative braces are believed to improve knee outcomes by contributing to better restoration of knee extension and also are believed to protect the healing graft by decreasing the mechanical load and by limiting excessive tibial rotation in the early post-operative period [9, 10, 22, 23]. However, the benefit of post-operative bracing after ACLR has been questioned, with many studies demonstrating no significant difference in outcomes between braced and non-braced groups [8, 13–19]. Fewer studies have compared the early functional outcome associated with post-ACLR brace use, with the majority of them studying long-term outcomes (2 to 5 years follow-up). So, this study was conducted to evaluate the early functional outcome of ACLR with or without a meniscal procedure associated with post-operative rehabilitative brace use and to help understand whether immediate post-operative bracing after ACLR was justified or not.
All the patients in our study had a negative Lachman test and no pivot shift instability at 12 weeks of follow-up. Likewise, there was no significant difference in the Lysholm knee scores between the two groups, and at the final follow-up, a statistically significant increase as compared with pre-operative measurement was seen in each group (93.88 ± 6.06 in the control group and 95.00 ± 5.15 in the case group). We observed good clinical results at 12 weeks of follow-up, which provide evidence of an efficient surgical technique and well-structured post-operative rehabilitation protocol, irrespective of brace use. Many studies have observed the knee scores at long-term follow-up only. In the study by Risberg et al., the patients in the braced group had significantly improved knee function compared with the patients in the non-braced group at the 3-month follow-up based on the Cincinnati knee scores but observed no difference at the final follow-up at 2 years [13]. Ours is the first study that evaluated Lysholm knee scores at the 3-month follow-up visit.
In this study, the ROM (flexion as well as hyperextension) and VAS scores for pain between the two groups were not significantly different. There was a progressive restoration of flexion and hyperextension ROM, along with a progressive decrease in VAS scores for pain at every visit after surgery in both groups till the final follow-up. These were comparable to the observations of Mӧller et al. [19] The progression of restoration of knee flexion was quite similar to the study by Mӧller et al., but restoration of extension was better in the patients of our study. Brandsson et al. [18] had observed less pain (lower VAS scores) in their braced patients as compared to non-braced patients at 2 weeks post-operatively, but we found no such difference between our study groups at similar follow-up periods.
The thigh girth difference at 12 weeks follow-up was not significantly different between the two groups. In the randomized controlled trial by Risberg et al., they observed that post-operative bracing (2 weeks of rehabilitative brace followed by 10 weeks of functional brace after surgery) increased the risk of thigh muscle atrophy at 12 weeks [13]. However, we used a rehabilitative brace for 4 weeks in the control group and observed no thigh atrophy in either of the groups at the final follow-up. Our rehabilitation protocol consisted of immediate knee ROM and isometric exercises in all the patients from the first post-operative day, and physiotherapy was carefully scrutinized even after the patient was discharged from the hospital, which contributed to good progressive restoration of thigh girth after surgery.
Regarding satisfaction scores (SF-12), there was no difference between the two groups in terms of the physical component summary (PCS-12) scores, but the mental component summary (MCS-12) scores were significantly higher in the non-braced group than in the braced group (P value 0.006). This correlated with many patients complaining of discomfort associated with brace use, although they did not experience much limitation in their physical performance. Furthermore, four patients experienced either bruising or abrasion associated with brace use, which may have contributed to lower overall MCS-12 scores in the control group. Other studies have shown that patients have reported either problems with brace use or feelings of discomfort. McDevitt et al. observed that 21% of the patients (military recruits) in the brace group complained of problems and did not wear the brace for the full duration of the study (functional knee brace for one year) as based on their compliance questionnaire [15]. Risberg et al. reported that 10% of the patients in the brace group had not complied with the bracing protocol (2 weeks of rehabilitative brace followed by 10 weeks of functional brace) [13]. However, Mӧller et al. [19] and Mueller et al. [24] observed that all the patients in the brace group were compliant with the bracing protocol (6 weeks of rehabilitative brace). Similarly, in this study as well the patients were compliant with brace use despite some complaints of discomfort, probably because of the shorter duration of brace use of 4 weeks.
Our study had some limitations. Firstly, it was a single-center study with a short follow-up duration, so long-term results might not match with the short-term observation, and the progression and long-term effects of complications could not be studied. Secondly, objective measurement of laxity and rotational instability could not be done in this study. Thirdly, there was a risk of recall bias when recording satisfaction scores, as data collection could not be done immediately after discontinuation of brace use in the control group.
Conclusion
There was no significant difference in early functional outcome between the braced and non-braced groups following ACLR with or without a meniscal procedure. Better SF-12 mental component summary scores were seen in the non-braced group, which indicated possible mental discomfort in patients with brace use. Given these observations, in terms of early functional outcomes, the routine use of a rehabilitative brace after ACLR does not appear to be beneficial.
Acknowledgements
The authors would like to acknowledge Dr. Ujwal Gautam for his support in statistical analysis.
Author Contributions
All the authors contributed to the study's conceptualization. NR, AJ, BB, NS, and IP designed the study. NR and SG collected the data. NR, AJ, BB, NS, RB, and RS contributed to the analysis and interpretation of data. NR wrote the manuscript with support from AJ. All authors discussed the results and approved the final version of the manuscript.
Funding
No funding was received for conducting this study.
Data Availability
The data for this study are available on request.
Declarations
Conflict of Interest
The authors declare that they have no conflict of interest.
Ethical Approval
This study was performed in line with the principles of the Declaration of Helsinki. Approval was obtained from the B&B Institutional Review Committee (Approval number: B&BIRC-22-26).
Informed Consent
Informed consent was obtained from all the participants of this study.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data for this study are available on request.