The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- International Hip Outcome Tool (iHOT-33)
研究概览
简要总结
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative.
详细描述
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative. The primary objective is to compare the effects of WBAT or PWB restrictions on PROMS (International Hip Outcome Tool (iHOT33)) and clinical measures following arthroscopic intervention for FAI up to one-year post-operative. The secondary objective will be to assess differences in return to sport (RTS) PROMS, functional performance, and lower extremity kinetics, kinematics, and muscle activity during in patients randomized to either WBAT or PWB at six- and 12-months post-operative. The goal will be to answer if there are differences between a WBAT versus PWB rehabilitation protocol on patient-reported quality of life as measured by the International Hip Outcome Tool (iHOT33) at 12-m post-operative for patients undergoing primary hip arthroscopy for the treatment of FAI.
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
Patients and surgeons will not be blinded to group allocation (weight-bearing status). The study Research Coordinator will perform randomization therefore they will also not be blinded to group allocation. The assessor for the functional and return to sport outcomes will be blinded to group allocation. To protect blinding, before each functional testing appointment, the blinded tester will remind patients not to reveal their group (weightbearing status).
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 - 50 years of age at time of surgery
- •Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3 criteria below must be met:
- •Symptoms of motion- or position-related pain in the hip or groin
- •Clinical signs consistent with FAI such as: decreased hip flexion and internal rotation, or positive impingement sign
- •Radiographic evidence (on BOTH x-ray AND non-contrast MRI) of intra-articular pathology consistent with FAI as determined by the treating surgeon.
- •Failed conservative interventions of at least 3 months (i.e. physiotherapy)
- •Have symptom relief with intra-articular injection of local anaesthetic
- •Unilateral or bilateral surgical intervention (note: unilateral required to ensure the weight bearing guidelines are followed)
- •Are willing to be followed for 12 months post-operative.
- •Eligibility for 'return to sport' cohort:
- •Additional assessment measures related to return to sport will be collected on the patient who meet the following criteria:
- •are or were previously actively involved in sport as indicated by a pre-operative Hip Sports Activity Scale score of four of greater
- •indicate a post-operative goal to return to sport following their procedure
排除标准
- •Previous surgery on the affected hip, or other major lower extremity orthopaedic surgery
- •Active joint or systemic infection, significant muscle paralysis, significant lower extremity or medical comorbidity that could alter the effectiveness of the surgical intervention (e.g. polymyalgia rheumatica)
- •Unable to speak or read English/French
- •Unable or unwilling to be followed for 1 year or complete functional testing
- •Presence of chronic pain syndromes
- •History of pediatric hip disease (i.e. Slipped Capital Femoral Epiphysis, Legg-Calve-Perthes Disease)
- •Ongoing litigation or compensation claims related to the hip (including Workers' Compensation)
- •Radiographic:
- •Osteoarthritis greater than Tönnis Grade 1 on affected hip
- •Lateral central edge angle <19°
- •Dysplasia in patients with broken Shenton line (i.e. Severe acetabular deformity present)
结局指标
主要结局
International Hip Outcome Tool (iHOT-33)
时间窗: 12 months
The iHOT uses 33 questions to measure health-related quality of life. It is the primary outcome and has been validated for use in this population. Questions are evaluated on a 100-point visual analog scale (VAS) response format, where "0" represents the worst possible quality of life, and "100" represents the the best.
次要结局
- Hip Isometric Muscle Strength(12 months)
- Hip Isokinetic Muscle Strength(12 months)
- Hop Tests(12 months)
- Computed Tomography (CT) Scan(0 months)
- The Copenhagen Hip and Groin Outcome Score (HAGOS)(12 months)
- Postoperative Pain and Medication(14 days)
- Non-contrast MRI(0 months)
- Hip Return to Sport after Injury scale (Hip-RSI)(12 months)
- Single Assessment Numeric Evaluation (SANE) score(12 months)
- Hip Sports Activity Scale (HSAS)(12 months)
- Rate of surgical complications, re-operations and revision surgeries(12 months)
- 5-0-5 Change of Direction (505)(12 months)
- Electromyography of the gluteal muscles(12 months)
- Jump Testing(12 months)