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

October 10, 2018 updated by: University of Oulu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90220
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
Time Frame: 18 months
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications in treatment of achilles tendon rupture.
Time Frame: 18 months
Complications are re-rupture and postoperative infection.
18 months
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.
Time Frame: 18 months
We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evo-rad-akilles-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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