Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Subjective results in conservative and operative treatment of Achilles tendon rupture.
研究概览
简要总结
The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in 1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop technique either without augmentation or with one central down-turned gastrocnemius fascia flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. Mean follow-up time is 14 years.
Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better result than would end-to-end suture repair with use of the Krackow locking loop surgical technique in long-term 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
- Single (Investigator)
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
- •Total achilles tendon rupture diagnose.
排除标准
- •more than 7 days old rupture, local corticosteroids injection in around the achilles tendon, rupture was open/ there where skin problems over achilles tendon area, patient lived abroad, if the main author was unavailable, or patient refused to participate.
研究组 & 干预措施
End-to-end suturation without augmentation
干预措施: End-to-end suturation without augmentation (Procedure)
End-to-end suturation with augmentation
干预措施: End-to-end suturation with augmentation. (Procedure)
结局指标
主要结局
Subjective results in conservative and operative treatment of Achilles tendon rupture.
时间窗: 14 years
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.
Objective results in operative treatment of Achilles tendon rupture.
时间窗: 14 years
Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
次要结局
- Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture(14 years)