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

Study Overview
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Brief Summary
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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.

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

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Procedure: End-to-end suturation without augmentation
* Procedure: End-to-end suturation with augmentation.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: End-to-end suturation without augmentation<br> | Procedure: End-to-end suturation without augmentation<br>* End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.<br>|
| Experimental: End-to-end suturation with augmentation<br> | Procedure: End-to-end suturation with augmentation.<br>* End-to-end suturation with augmentation; End-to-end suturation as above with a 10 mm wide central gastrocnemius aponeurosis flap, as proposed by Silfverskjöld.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture | We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation. | 14 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles tendon rupture, operative treatment, elongation, long-term follow up.