Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT02012803
First received: November 27, 2013
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Subjective and objective results in conservative and operative treatment of Achilles tendon rupture. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Complications are re-rupture and postoperative infection.

  • Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.


Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02012803

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02012803     History of Changes
Other Study ID Numbers: Evo-rad-akilles-2
Study First Received: November 27, 2013
Last Updated: May 27, 2015
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
Achilles tendon rupture
treatment, elongation
operative treatment of achilles tendon rupture
conservative treatment of achilles tendon rupture

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 29, 2015