Prospective Study: the Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tom Lootens
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change in AOFAS
研究概览
简要总结
The aim of this study is to investigate the point or nonsense of treating cartilage lesions at the level of the first metatarsophalane joint. To date, no clear guidelines have been found in the literature with regard to the treatment of cartilage lesions at the MTP I joint during corrective surgery for hallux valgus, nor has it been investigated whether this can have an effect on the clinical outcome.
详细描述
A randomized, single surgeon study in which two groups will be compared with each other:
Group 1: 50 patients in whom no treatment of the cartilage lesions is performed: these patients have no cartilage lesion or a grade I cartilage lesion at the MTP I joint that has been found to be operative. The grade of the cartilage lesions will be determined on the basis of the ICRS scale and an MS Hololens.
Group 2: 50 patients with a cartilage lesion> grade 1 found during surgery. Whether or not to treat the cartilage injury will be randomly determined. 50 envelopes will be made with 25 treat, 25 not to treat. Just before surgery, Dr. T. Lootens an envelope will be drawn which will determine the further policy of the operation:
Group 2A: 25 patients who are not treated for the cartilage injury. Group 2B: 25 patients who are treated for the cartilage injury by means of debridement of the lesion and microfracture.
The patients who will undergo surgery for hallux valgus will be seen pre-operatively at the outpatient clinic by the investigators. During this consultation, an explanation will be given about the research and the participant will have to sign an informed consent before participating in the study. Here, the participant will also receive an envelope with questionnaires (AOFAS score / SF 36 score / VAS pain and satisfaction), which they will fill out on the day of surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hallux valgus
排除标准
- •younger than 30 years, older than 60 years
- •extra pathologies other than hallux valgus
结局指标
主要结局
Change in AOFAS
时间窗: 10 days, 5 weeks, 4 months, 1 year
American Orthopaedic Foot and Ankle Society (AOFAS) score - combines a clinician-reported and a patient-reported part for measuring the outcome of treatment in patients who sustained a complex hindfoot injury based on pain, function and alignment: 0 (bad outcome) to 100 (very good outcome)
Change in VAS pain
时间窗: 10 days, 5 weeks, 4 months, 1 year
Visual Analogue Scale pain score - 0 (no pain) to 10 (worse pain)
Change in SF36
时间窗: 10 days, 5 weeks, 4 months, 1 year
Short Form 36 (SF-36) Health Survey - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
次要结局
- Change in VAS Patient satisfaction(10 days, 5 weeks, 4 months, 1 year)
研究者
Tom Lootens
Principle Investigator
Algemeen Ziekenhuis Maria Middelares