Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
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|ClinicalTrials.gov Identifier: NCT02018224|
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : September 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendon Rupture||Procedure: End-to-end suturation without augmentation Procedure: End-to-end suturation with augmentation.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||March 2014|
|Experimental: End-to-end suturation without augmentation||
Procedure: End-to-end suturation without augmentation
End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.
|Experimental: End-to-end suturation with augmentation||
Procedure: End-to-end suturation with augmentation.
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.
- 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.
- Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture [ Time Frame: 14 years ]We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018224
|Oulu University Hospital|
|Oulu, Finland, 90220|