Back to resultsAchilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
Primary Purpose
Achilles Tendon Rupture
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
Conservative treatment of achilles tendon rupture
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles tendon rupture, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture
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.
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Operative treatment
conservative treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Complications in treatment of achilles tendon rupture.
Complications are re-rupture and postoperative infection.
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
1. Study Identification
Unique Protocol Identification Number
NCT02012803
Brief Title
Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
Official Title
Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2017 (Actual)
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 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.
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, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative treatment
Arm Type
Experimental
Arm Title
conservative treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative treatment of achilles tendon rupture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Complications in treatment of achilles tendon rupture.
Description
Complications are re-rupture and postoperative infection.
Time Frame
18 months
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
18 months
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:
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.
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28282504
Citation
Heikkinen J, Lantto I, Flinkkila T, Ohtonen P, Niinimaki J, Siira P, Laine V, Leppilahti J. Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments. Am J Sports Med. 2017 May;45(6):1395-1404. doi: 10.1177/0363546517694610. Epub 2017 Mar 10.
Results Reference
derived
PubMed Identifier
27307495
Citation
Lantto I, Heikkinen J, Flinkkila T, Ohtonen P, Siira P, Laine V, Leppilahti J. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures. Am J Sports Med. 2016 Sep;44(9):2406-14. doi: 10.1177/0363546516651060. Epub 2016 Jun 15.
Results Reference
derived
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Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
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