Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Procedure: End-to-end suturation without augmentation; Procedure: End-to-end suturation with augmentation.

• Registration Number: NCT02018224
• Lead Sponsor: University of Oulu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Primary Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
End-to-end suturation without augmentation	End-to-end suturation without augmentation	-
End-to-end suturation with augmentation	End-to-end suturation with augmentation.	-

Primary Outcome Measures

Name	Time	Method
Subjective results in conservative and operative treatment of Achilles tendon rupture.	14 years	Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.
Objective results in operative treatment of Achilles tendon rupture.	14 years	Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.

Secondary Outcome Measures

Name	Time	Method
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture	14 years	We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland