A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- MRI articular cartilage morphology
研究概览
简要总结
The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving optimized non-surgical treatment plus surgical realignment of the tibia, or optimized non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months follow-up will suggest favourable changes in patients undergoing surgical realignment when compared to patients receiving non-surgical treatment only.
详细描述
This two groups, parallel design randomized controlled trial will compare patients with medial compartment knee OA and varus alignment receiving optimized non-surgical treatment plus High Tibial Osteotomy (HTO) to similar patients receiving optimized non-surgical treatment only. All participants will receive non-surgical treatment that will be individualized to the patient and include medications, physiotherapy and nutritional seminars. The non-surgical treatment will include supervised physiotherapy and nutritional seminars once per week for 12 weeks, will be accompanied and followed by a home program, and follow-up appointments for potential modification every three months for the duration of the study. Participants randomized to surgery will also undergo medial opening wedge HTO after 12 weeks of optimized non-surgical treatment. Both groups will follow the same schedule of clinic visits throughout the 24 month follow-up period. MRI-derived measures of articular cartilage morphology, biological markers of articular cartilage degradation and synthesis, gait biomechanics and patient-reported outcomes will be assessed at baseline, 12 and 24 months follow-up.
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
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is the subject either:
- •25-55 years old?
- •Older than 55 but still active (ex. physical labour, regular recreational activities)?
- •Does this subject present with varus alignment? (Based on hip to ankle x-rays).
- •Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?
- •Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
排除标准
- •Has this subject had a previous HTO or joint replacement in either limb?
- •Is this subject likely to undergo bilateral HTO within the 2 year follow up period?
- •Does this subject have an unstable knee or ligament?
- •Does this subject have inflammatory or infectious arthritis of the knee?
- •Radiographic disease too advanced for HTO (ie. diffuse lateral compartment, patellofemoral joint OA and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or Kellgren and Lawrence grade
- •The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO.
- •Does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk?
- •Does this subject have a major neurological deficit that would affect gait?
- •Is this subject possibly pregnant or planning pregnancy?
- •Is this subject unable to read English?
- •Does this subject have a psychiatric illness that limits informed consent?
- •Is the subject unlikely to comply with study protocol?
结局指标
主要结局
MRI articular cartilage morphology
时间窗: Change from baseline to 24 months post operative
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
次要结局
- Numeric Rating Scale for Pain(Baseline, 12 and 24 months post operative)
- Gait Biomechanics(Baseline, 12 and 24 months post operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Change from baseline to 24 months post operative)
- Biological Markers of Disease Progression(Baseline, 12 and 24 months post operative)
- Short-Form 12 (SF12)(Change from baseline to 24 months post operative)
- Western Ontario Meniscal Evaluation Tool (WOMET)(Change from baseline to 24 months post operative)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Change from baseline to 24 months post operative)
- Isometric Strength Testing(Baseline, 12 and 24 months post operative)
- Intermittent and Constant Osteoarthritis Pain Index (ICOAP)(Change from baseline to 24 months post operative)
研究者
Trevor Birmingham
Professor
Western University, Canada