Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Subjective results in conservative and operative treatment of Achilles tendon rupture.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Total achilles tendon rupture diagnose.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Subjective results in conservative and operative treatment of Achilles tendon rupture.
Time Frame: 14 years
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.
Objective results in operative treatment of Achilles tendon rupture.
Time Frame: 14 years
Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
Secondary Outcomes
- Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture(14 years)