Back to resultsAchilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Primary Purpose
Achilles Tendon Rupture
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
End-to-end suturation without augmentation
End-to-end suturation with augmentation.
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles tendon rupture, operative treatment, elongation, long-term follow up.
Eligibility Criteria
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.
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
End-to-end suturation without augmentation
End-to-end suturation with augmentation
Arm Description
Outcomes
Primary Outcome Measures
Subjective 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 in operative treatment of Achilles tendon rupture.
Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02018224
First Posted
November 27, 2013
Last Updated
September 15, 2014
Sponsor
University of Oulu
1. Study Identification
Unique Protocol Identification Number
NCT02018224
Brief Title
Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Official Title
Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles tendon rupture, operative treatment, elongation, long-term follow up.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End-to-end suturation without augmentation
Arm Type
Experimental
Arm Title
End-to-end suturation with augmentation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
End-to-end suturation without augmentation
Intervention Description
End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.
Intervention Type
Procedure
Intervention Name(s)
End-to-end suturation with augmentation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective results in conservative and operative treatment of Achilles tendon rupture.
Description
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.
Time Frame
14 years
Title
Objective results in operative treatment of Achilles tendon rupture.
Description
Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
Time Frame
14 years
Secondary Outcome Measure Information:
Title
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture
Description
We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
Time Frame
14 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
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