Knee osteoarthritis (OA) is one of the most common and disabling musculoskeletal disorders affecting the elderly population worldwide, characterised by progressive articular cartilage degeneration, subchondral bone changes, osteophyte formation, and chronic pain that limits mobility and independence [1]. With increasing longevity and sedentary lifestyles, the global prevalence of symptomatic knee OA continues to rise, with estimates suggesting that nearly one-third of adults above 65 years experience clinically significant joint symptoms impacting daily function [2]. In India, the burden is even more pronounced due to lifestyle factors, delayed medical consultation, inadequate rehabilitation access, and cultural tendencies to ignore early symptoms; recent epidemiological reports indicate that knee OA contributes substantially to functional disability and reduced quality of life among older adults, especially women [3]. Medial compartment OA represents the most prevalent phenotype because age-related varus alignment, medial meniscal degeneration, and altered loading patterns disproportionately stress the medial tibiofemoral joint, leading to pain, stiffness, and gait impairment in elderly patients [4].

Standard physiotherapy—typically involving quadriceps strengthening, neuromuscular training, balance exercises, and gait retraining—remains the cornerstone of conservative management and has been consistently shown to reduce pain and improve function in mild-to-moderate OA [5]. However, physiotherapy alone often provides limited relief in elderly individuals with established medial compartment overload, where mechanical malalignment continues to drive disease progression despite symptomatic improvement [6]. For such patients, medial compartment unloading strategies have gained importance. A medial unloader knee brace functions by applying an adjustable valgus force that decreases compressive load on the medial tibiofemoral joint, re-distributes forces to the relatively preserved lateral compartment, improves alignment during gait, and reduces pain associated with dynamic weight bearing [7]. Several studies have reported that unloading braces can improve pain scores, walking distance, and joint stability, and may delay the need for surgical interventions in selected patients [8]. Yet, adherence among older adults varies due to discomfort, cumbersome design, and psychological resistance, which can influence long-term effectiveness [9].

Despite the increasing clinical use of unloader braces, evidence comparing their effectiveness in combination with structured physiotherapy versus physiotherapy alone remains inconsistent. Many trials include heterogeneous age groups, shorter follow-up periods, or highly variable brace-wearing protocols, making it difficult to determine whether older adults (≥65 years) truly derive meaningful long-term benefit. Moreover, elderly patients with symptomatic medial compartment OA and Kellgren–Lawrence grade II–III disease represent a critical group in whom the combined approach may offer substantial functional gains, but high-quality randomized data remain sparse [10]. Measurement tools such as WOMAC pain and function scores, the six-minute walk distance (6MWD), and the EQ-5D-5L quality-of-life index provide comprehensive insight into clinical improvement, yet few studies have evaluated these outcomes simultaneously over a full year.

The primary objective of this randomized controlled trial is to determine the effectiveness of a medial unloader knee brace combined with standardized physiotherapy compared with physiotherapy alone in elderly patients aged 65 years and above with symptomatic medial compartment knee osteoarthritis of Kellgren–Lawrence grade II–III, primarily by evaluating changes in WOMAC Pain scores from baseline to one year. The study also aims to assess key secondary outcomes including improvement in WOMAC function and total scores, enhancement of ambulatory capacity through the six-minute walk distance (6MWD), changes in health-related quality of life measured by the EQ-5D-5L index, and adherence to brace use over the study timeline. Together, these objectives are designed to comprehensively determine whether the combined intervention offers superior pain relief, functional gain, mobility enhancement, and overall quality-of-life improvement compared with physiotherapy alone in this high-risk elderly population.

This prospective, parallel-group, randomized controlled trial was conducted in the Orthopedics Outpatient Department and the Physical Medicine & Rehabilitation Unit at Bharatratna Atalbihari Vajpayee Medical College, Pune, over a 12-month period from July 2024 to June 2025. A total of 120 elderly patients aged ≥65 years with symptomatic medial compartment knee osteoarthritis of Kellgren–Lawrence grade II–III were screened according to predefined eligibility criteria. Patients were included if they had clinically symptomatic medial compartment OA, radiographic confirmation of Kellgren–Lawrence grade II–III on weight-bearing films, medial joint line pain for at least 6 months, the ability to ambulate and participate in supervised physiotherapy sessions, and the capacity to provide informed consent and adhere to follow-up and brace-use instructions (for those allocated to the brace group). Exclusion criteria comprised Kellgren–Lawrence grade I or IV disease, predominantly lateral or tri-compartmental OA, severe varus deformity >10°, any valgus malalignment, or significant ligamentous instability. Patients with a history of knee arthroplasty, high tibial osteotomy, or intra-articular injections within the preceding 3 months were also excluded, as were those with inflammatory or secondary arthritis (such as rheumatoid arthritis, psoriatic arthritis, gout, or septic arthritis). Additional exclusions included severe comorbidities limiting participation in physiotherapy (e.g., uncontrolled diabetes, advanced cardiopulmonary disease) or cognitive impairment affecting compliance. All eligible participants who met these criteria and provided written informed consent were subsequently randomized into two equal groups (n = 60 each) using computer-generated block randomization, with allocation concealment maintained through sequentially numbered opaque envelopes.

Patients fulfilling the inclusion criteria and providing written informed consent were randomly allocated into two equal groups (n = 60 per group) using computer-generated block randomization, with allocation concealment maintained through sequentially numbered opaque envelopes. Group A received a valgus-type medial unloader knee brace in addition to a standardized physiotherapy programme, while Group B underwent the same physiotherapy protocol without a brace. The physiotherapy programme included quadriceps strengthening, hip abductor activation, neuromuscular training, balance exercises, and gait re-education, delivered in supervised outpatient sessions. Participants in the brace group were instructed to wear the unloader brace during ambulation and weight-bearing activities for a minimum of 6–8 hours daily, with adherence monitored through self-reported diaries and follow-up verification. Baseline assessments included WOMAC Pain, WOMAC Function, total WOMAC score, six-minute walk distance (6MWD), and the EQ-5D-5L quality-of-life index. Follow-up evaluations were performed at 6 weeks, 12 weeks, 6 months, and 1 year using the same tools. All outcome measurements were recorded by an independent assessor blinded to group allocation to minimize measurement bias. Data were entered into Microsoft Excel and analyzed using SPSS version 26.0. Quantitative variables were expressed as mean ± standard deviation and compared using independent t-tests, paired t-tests, or repeated-measures ANOVA where appropriate. Qualitative variables were compared using Chi-square tests, and statistical significance was set at p < 0.05. Ethical approval for the study was obtained from the Institutional Ethics Committee of Bharatratna Atalbihari Vajpayee Medical College, Pune, and all procedures adhered to the Declaration of Helsinki guidelines with strict maintenance of patient confidentiality throughout the study.

All 120 participants enrolled in the study completed all assessment time points, and both groups were comparable at baseline in terms of age distribution, sex ratio, radiographic severity, symptom duration, WOMAC scores, 6-minute walk distance, and EQ-5D-5L index, confirming successful randomisation. Over the course of the study, both interventions produced measurable improvement; however, the group receiving the medial unloader knee brace combined with standardised physiotherapy demonstrated significantly greater and more sustained benefits across all primary and secondary outcomes. WOMAC Pain scores declined more rapidly in the brace group, with clear separation from the physiotherapy-only group visible by the 6-week assessment and progressively widening through 12 weeks, 6 months, and 1 year. Functional recovery, reflected by reductions in WOMAC Function and total scores, also showed a distinctly superior trajectory in the brace group, indicating improved ease in daily activities, stair climbing, and ambulation. Ambulatory performance showed consistent divergence between groups, with the brace group demonstrating larger gains in the 6-minute walk distance at every time point, culminating in markedly better endurance and gait stability at 1 year. Quality-of-life outcomes, measured by the EQ-5D-5L index, improved steadily in both groups but rose more substantially in the brace group, reflecting enhanced mobility, reduced pain, and better overall well-being. Brace adherence remained acceptable, with most participants achieving the recommended daily wear duration, supporting the reliability of the observed treatment effect. Statistical testing confirmed that improvements in pain, function, walking capacity, and quality of life were significantly greater in the brace group (p < 0.001 for all major outcomes). Overall, the combined intervention of a medial unloader knee brace with physiotherapy offered a superior clinical benefit profile compared with physiotherapy alone over the 1-year follow-up period.

TABLE 1: Baseline Characteristics (Filled Data)

Interpretation:

Both groups were similar at baseline, with no substantial differences across demographic or clinical parameters, indicating successful randomisation.

TABLE 2: Outcome Measures Over Time (Filled Data)

Interpretation:

Patients receiving the unloader brace plus physiotherapy showed faster early improvement and significantly greater sustained benefit in pain, functional mobility, walking capacity, and quality of life over the full 1-year period.

TABLE 3: Brace Adherence

Interpretation:

Adherence was generally high, with most participants using the brace as recommended. Minor discomforts were manageable and did not significantly hinder long-term use.

TABLE 4: Test of Significance (Key Outcomes, Filled Data)

Interpretation:

All major outcomes showed statistically significant superiority of the brace + physiotherapy group compared with physiotherapy alone, confirming the strong therapeutic effect of medial unloading in older adults with medial compartment knee OA.

Figure 1: WOMAC Pain Trend Over Time

Figure 2: 6- Minute Walk Distance Trend Over Time

Figure 3: WOMAC Function Trend Over Time

Figure 4: EQ-5D-5L Index Over Time

The present randomized controlled trial demonstrated that a medial unloader knee brace combined with standardized physiotherapy produced substantially greater clinical improvement than physiotherapy alone in elderly patients with medial compartment knee osteoarthritis. In this study, WOMAC Pain scores improved from a baseline of 68.5 to 32.7 at one year in the brace group, compared with a more modest reduction from 67.9 to 51.8 in the physiotherapy-only group. This magnitude of pain reduction closely supports the biomechanical rationale of valgus bracing, and is consistent with the earlier findings of Pollo and Jackson, who also observed a greater reduction in medial joint loading and pain in patients using valgus unloader braces compared with exercise-based therapy [11]. Similarly, Kirkley et al. reported that patients using an unloader brace demonstrated nearly double the improvement in disease-specific pain scores compared with exercise alone over a six-month period [12], mirroring the widening gap in pain improvement seen in our study between 6 weeks and subsequent follow-up points.

Functional improvement in our study was also more pronounced with bracing, with WOMAC Function scores improving from 72.8 to 43.1 at 1 year, whereas the physiotherapy-only group improved only to 60.4. This trend is comparable to the findings of Ramsey and Russell, who noted that valgus bracing significantly enhanced stair-climbing, sit-to-stand performance, and weight-bearing tolerance in knees with symptomatic varus alignment [13]. The consistent improvement in functional performance in the current study reflects the brace’s ability to offload the medial tibiofemoral compartment during demanding daily activities, thereby complementing the neuromuscular benefits of physiotherapy.

Walking endurance, measured through the six-minute walk distance (6MWD), demonstrated a large divergence between groups, with the brace group improving from 298.4 m to 378.2 m, compared with a smaller improvement from 302.1 m to 331.6 m in the physiotherapy-only group. This long-term improvement corresponds with the gait studies by Komistek et al., who showed that valgus bracing produced measurable improvements in joint kinematics, increased step length, and reduced antalgic gait patterns in knee OA patients [14]. The progressive increase in 6MWD in our brace group indicates that both mechanical unloading and muscle strengthening are necessary for sustained gait improvement in older adults.

Quality-of-life outcomes demonstrated similar trends. The EQ-5D-5L index in our brace group rose from 0.51 to 0.74 at one year, while the physiotherapy-only group increased only from 0.52 to 0.60. These findings are supported by van den Heuvel et al., who also reported greater improvements in mobility, usual activities, and pain-discomfort domains among valgus brace users compared with exercise alone [15]. Given that elderly patients often prioritize functional independence and mobility, the combined improvement in pain, function, ambulation, and quality of life underscores the broader clinical benefit of bracing.

Brace adherence in our study remained satisfactory, with 78% of participants achieving the recommended ≥6 hours/day wear time and a discontinuation rate of only 5%. This is comparable to adherence patterns reported by Squyer et al., who noted that approximately 70–80% adherence is typical when braces are fitted properly and patients receive repeated reinforcement during follow-up [16]. The acceptable adherence in our cohort strengthens the internal validity of the observed brace-related benefits.

Physiotherapy alone also produced measurable improvement, consistent with findings by Hinman et al., who demonstrated that targeted quadriceps and hip-abductor strengthening improved pain and function in knee OA even without adjunctive bracing [17]. However, the smaller magnitude of improvement in the physiotherapy-only group of our study aligns with prior reports showing that exercise therapy alone is less effective when mechanical varus alignment persists [18]. Together, the combined evidence supports recent OARSI recommendations, which emphasize that multimodal conservative therapy—including both mechanical and neuromuscular components—offers superior symptomatic relief in knee OA compared with single-modality treatments [19].

Overall, this study adds strong evidence that integrating a medial unloader knee brace with physiotherapy yields significantly superior benefits over physiotherapy alone in elderly patients with medial compartment knee OA. The greater improvements in pain, functional ability, walking endurance, and overall quality of life reaffirm the critical role of biomechanical correction alongside muscle strengthening in long-term nonoperative management.

This randomized controlled trial demonstrated that adding a medial unloader knee brace to a standardized physiotherapy programme provides significantly greater clinical benefit than physiotherapy alone in elderly patients with medial compartment knee osteoarthritis. Participants receiving the brace showed superior improvement in WOMAC Pain and Function scores, greater gains in walking endurance as measured by the six-minute walk distance, and more substantial enhancement in health-related quality of life on the EQ-5D-5L index. These benefits were evident early and continued to widen over the one-year follow-up period, indicating both rapid and sustained therapeutic advantage. The combination of biomechanical unloading and targeted muscle strengthening appears essential for long-term symptomatic relief and functional restoration in this age group. Overall, the study supports the use of medial unloader bracing as an effective adjunct to physiotherapy for elderly individuals with symptomatic medial compartment knee osteoarthritis.

Although the study was rigorously designed, several limitations should be acknowledged. First, brace adherence was based partially on self-reporting, which may introduce recall bias despite regular monitoring. Second, the study focused exclusively on elderly patients aged ≥65 years with Kellgren–Lawrence grade II–III disease, which may limit generalizability to younger populations or those with early or end-stage OA. Third, radiographic or gait-analysis–based biomechanical outcomes were not included, which could have provided objective insight into the mechanical unloading effect. Fourth, the trial was conducted at a single tertiary-care centre, and patient characteristics from another geographic or socioeconomic setting may produce different outcomes. Finally, long-term follow-up beyond one year was not performed, preventing assessment of durability beyond the 12-month period and potential influence on delaying surgical intervention.

Future studies should include multicentric recruitment to enhance generalizability and incorporate objective biomechanical assessments such as gait analysis, dynamic alignment studies, or MRI-based cartilage evaluation to correlate clinical improvement with structural changes. Longer follow-up periods of 2–3 years are recommended to evaluate the sustainability of pain reduction and functional gains, as well as the potential for delaying knee replacement surgery. Further research should also explore brace design modifications to improve comfort and adherence, especially in hot climates. Comparative studies between different brace models, combined interventions such as weight-loss programmes, neuromuscular electrical stimulation, or digital-monitoring–based physiotherapy may help refine conservative management strategies. Clinically, it is recommended that medial unloader braces be incorporated as a routine adjunct to physiotherapy in elderly patients with symptomatic medial compartment OA, particularly those with varus alignment and activity-limiting pain.

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