A Stratified, Partially Randomized Study Comparing Autologous Semitendinosus Tendon Graft and Meniscal Allograft Transplantation in Young Adults With Post-Meniscectomy Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score
研究概览
简要总结
This multicenter, stratified, partially randomized clinical trial aims to compare autologous semitendinosus tendon graft and meniscal allograft transplantation (MAT) in young adults with post-meniscectomy syndrome. The meniscus plays a critical role in load distribution, shock absorption, and joint stability. After meniscectomy, insufficient meniscal tissue often leads to persistent pain, swelling, and functional decline, increasing the risk of early osteoarthritis.
Two reconstructive strategies are clinically available: MAT provides immediate biomechanical function but requires donor matching and carries higher costs, while autologous tendon graft offers stable supply and no immunologic risk but lacks long-term clinical validation.
In this study, 40 patients aged 18-45 years will be enrolled. Participants will be allocated into four groups (randomized MAT, randomized autograft, patient-preference MAT, patient-preference autograft). All procedures will use a two-tunnel fixation technique with additional internal brace support.
The primary endpoint is the improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) at 24 months postoperatively. Secondary endpoints include MRI-based assessment of graft morphology and extrusion, reoperation rate, complications, patient satisfaction, and return-to-sport time.
This trial will provide critical evidence regarding the comparative effectiveness and feasibility of tendon autograft versus meniscal allograft in real-world clinical settings, potentially informing surgical decision-making and future treatment guidelines for post-meniscectomy syndrome.
详细描述
Post-meniscectomy syndrome represents a challenging condition in young adults, characterized by persistent pain, swelling, and functional impairment after partial or subtotal meniscectomy. The lack of sufficient meniscal tissue predisposes patients to abnormal tibiofemoral loading and early onset osteoarthritis. Current reconstructive options remain limited, and there is no consensus on the optimal surgical strategy.
Meniscal allograft transplantation (MAT) has been the most widely accepted method, offering immediate restoration of meniscal morphology and load-distributing capacity. However, MAT is constrained by donor availability, graft costs, and local regulations. In contrast, autologous tendon grafts-most commonly using semitendinosus-are readily available, carry no risk of rejection, and reduce cost barriers. Early biomechanical and translational studies suggest that autologous tendon grafts may adapt to meniscal-like properties, yet long-term clinical data remain scarce.
This trial employs a stratified, partially randomized design to balance methodological rigor with patient autonomy and ethical feasibility. Participants are assigned to autologous tendon graft or MAT either through randomization or patient preference, allowing assessment of outcomes under both controlled and real-world conditions. All procedures are standardized across participating centers, utilizing a two-tunnel fixation technique and augmented with an internal brace (Fibertape) to enhance graft stability.
Outcomes will be assessed over 24 months, including validated patient-reported measures (KOOS, IKDC, Tegner), MRI-based graft evaluation (volume, signal, extrusion, morphology), reoperation rates, complications, satisfaction, and return-to-sport. By integrating randomized comparison with pragmatic elements, this study aims to generate clinically applicable evidence on the relative benefits and limitations of autologous tendon graft versus MAT. The findings are expected to inform surgical decision-making, optimize patient outcomes, and guide future treatment recommendations for young patients suffering from post-meniscectomy syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Postoperative MRI and patient-reported outcome measures (PROMs) will be evaluated by independent assessors blinded to treatment allocation. Participants, surgeons, and investigators will be aware of the intervention due to the surgical nature of the study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 45 years
- •History of partial meniscectomy > 6 months prior to enrollment
- •Symptomatic post-meniscectomy syndrome (knee pain, swelling, or functional decline)
- •MRI showing cartilage status ≤ Outerbridge grade 2
- •Knee joint stability (or stabilized during the index surgery)
- •Body mass index (BMI) < 30
- •Willingness to provide written informed consent
排除标准
- •Tibial slope > 16°
- •Radiographic or arthroscopic evidence of advanced cartilage degeneration (Outerbridge > 2 or ICRS ≥ 3)
- •Presence of inflammatory arthritis or systemic inflammatory joint disease
- •History of cartilage repair surgery
- •Malalignment > 5° not corrected
- •Untreated ligamentous instability
- •Any other condition judged by the investigator to compromise study participation or outcomes
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score
时间窗: Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)
The KOOS questionnaire evaluates knee-related symptoms, pain, activities of daily living, sports/recreation function, and knee-related quality of life. The primary endpoint is the change in KOOS total score from baseline to 24 months postoperatively.
Knee Injury and Osteoarthritis Outcome Score
时间窗: Baseline, 6, 12, and 24 months after surgery (primary analysis at 24 months)
The KOOS questionnaire evaluates knee-related symptoms, pain, activities of daily living, sports/recreation function, and knee-related quality of life. The primary endpoint is the change in KOOS total score from baseline to 24 months postoperatively.
次要结局
- MRI-Based Graft Evaluation(12 and 24 months postoperatively)
- IKDC (International Knee Documentation Committee) Subjective Knee Evaluation(Baseline, 6, 12, and 24 months after surgery)
- Tegner Activity Scale(Baseline, 6, 12, and 24 months after surgery)
- Reoperation Rate(Up to 24 months postoperatively)
- Complications(Within 24 months after surgery)
- Return to Sport Time(Up to 24 months postoperatively)
- MRI-Based Graft Evaluation(12 and 24 months postoperatively)
- IKDC (International Knee Documentation Committee) Subjective Knee Evaluation(Baseline, 6, 12, and 24 months after surgery)
- Tegner Activity Scale(Baseline, 6, 12, and 24 months after surgery)
- Reoperation Rate(Up to 24 months postoperatively)
- Complications(Within 24 months after surgery)
- Patient Satisfaction(12 and 24 months postoperatively)
- Return to Sport Time(Up to 24 months postoperatively)