Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months. Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.

Official Title
-----------------
Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial

Conditions
-----------------
Achilles Tendon Rupture

Intervention / Treatment
-----------------
* Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
* Other: Conservative treatment of achilles tendon rupture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion. Exclusion Criteria: earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative treatment<br> | Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture<br>* Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.<br>|
| Active Comparator: conservative treatment<br> | Other: Conservative treatment of achilles tendon rupture<br>* Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective and objective results in conservative and operative treatment of Achilles tendon rupture. | Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications in treatment of achilles tendon rupture. | Complications are re-rupture and postoperative infection. | 18 months | 
| 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. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles tendon rupture, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture