Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
|ClinicalTrials.gov Identifier: NCT02012803|
Recruitment Status : Unknown
Verified May 2015 by University of Oulu.
Recruitment status was: Active, not recruiting
First Posted : December 16, 2013
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendon Rupture||Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture Other: Conservative treatment of achilles tendon rupture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
|Experimental: Operative treatment||
Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
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.
|Active Comparator: conservative treatment||
Other: Conservative treatment of achilles tendon rupture
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.
- Subjective and objective results in conservative and operative treatment of Achilles tendon rupture. [ Time Frame: 18 months ]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.
- Complications in treatment of achilles tendon rupture. [ Time Frame: 18 months ]Complications are re-rupture and postoperative infection.
- Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture. [ Time Frame: 18 months ]We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012803
|Oulu University Hospital|
|Oulu, Finland, 90220|