- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018224
Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Oulu, Finland, 90220
- Oulu University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Experimental: End-to-end suturation with augmentation
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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14 years
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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.
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14 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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14 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- evo-rad-akilles3
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Clinical Trials on Achilles Tendon Rupture
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University of OuluCompletedAchilles Tendon RuptureFinland
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Hvidovre University HospitalCompletedAchilles Tendon RuptureDenmark
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