Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Migration in mm measured with RSA (Roentgen Stereometric Analysis)
研究概览
简要总结
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Hitherto the golden standard has been autograft taken from iliac crest but there are donorsite related problems and limited amount available.
Recently injectable and resorbable calciumphosphate-cements have been introduced and used with promising results in fractures of the distal radius, calcaneus and lateral tibial condyle.
These new cements seem to be a good alternative to other bone substitutes providing high initial strength that might promote early mobilisation; it resorbs and promotes osteoconduction securing safe healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies with three different bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement Calcibon and as control a group with an empty gap.
Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as a randomised prospective clinical trial including 45 patients with a planned 2 years follow-up period.
Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.
Routine standing x-rays is performed. Stability is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.
This combined with urine and serum bone-healing markers gives a very precise picture of the healing in the bone-gap.
To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen type II degradation are measured.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- •Candidate for proximal tibial medial open-wedge osteotomy
- •Signed informed consent
排除标准
- •Prednisolone treatment.
- •NSAID treatment.
- •BMI > or =
- •Previous surgery in lateral knee compartment.
- •Secondary Arthrosis following fracture(s) of the tibial condyle(s).
- •Lack of informed consent.
结局指标
主要结局
Migration in mm measured with RSA (Roentgen Stereometric Analysis)
时间窗: postoperative, at 3 month, 1 and 2 years
次要结局
- MR of the knee(4 weeks preoperative, preoperative, at 1 and 2 years postoperative.)
- Markers of chondral degradation(preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative)
- Markers of bone synthesis and degradation(preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative)
- Hip-Knee-Ankle axis(3 month, 1 and 2 years.)
- Clinical scores: KOOS, Lysholm, SF12, Knee Score(Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years)
- Histomorphometric evaluation of bone healing and osseous integration of cement(1 year)