Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing

February 4, 2010 updated by: Linkoeping University

Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial

The purpose of this study is to measure the mechanical properties of healing Achilles tendons in humans after early controlled weightbearing, compared with a control group in a randomized, single-blinded trial. The mechanical properties are measured using radiostereophotogrammetic x-rays (RSA).

Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles tendon.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patient with an acute Achilles tendon rupture coming to the local emergency room are asked to participate in our study. Patients have to be between 18 and 60 years and they must not have any contraindications for surgical treatment.

Patients who are interested in participating in the study receive oral and in written information about the study of the main investigator of the study (Thorsten Schepull). Patients who then agree to participate in the study are registered for surgery. All patients are operated the same way in local anaesthesia within 5 days after injury. We are going to use a conventional open technique with a dorso-medial approach. Tendon ends are going to be adapted with a resorbable suture and we are going to implant 2 Tantalum beads (size 0.8 mm) in the distal part of the tendon and 2 Tantalum beads with the same size in the proximal part. A short leg cast is going to be applied with the foot in the equinus position.

Randomization to early weightbearing or control group is done postoperatively

Group 1 (control group):

The short leg cast that is going to be applied during operation with the foot in the equinus position is removed after 3.5 weeks and a new cast is applied with the ankle in a neutral position for another 3.5 weeks. The new cast is removed after 3.5 weeks (cast treatment in total 7 weeks). Physiotherapy starts after cast removal, following our previous hospital routines. Full activity, including sports, is allowed after approximately 5 months.

We are going to perform RSA after 7 weeks (within 15 minutes after cast removal), after 19 weeks i.e. 12 weeks after cast removal, and after 52 weeks (12 months). A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. The first force applied to the pedal is 25 N and the second is 150 N. The same day CT scans of the injured Achilles tendon are taken.

Group 2 (early weightbearing):

The cast from surgery i removed after 2 weeks and replaced by a removable Air Cast Walker. The patient is provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients are using the Air Cast Walker for 5 weeks (cast treatment in total 7 weeks), but is supposed to remove the cast twice a day and supposed to use the training pedal.

Follow-ups at 7 (cast removal), 19 and 52 weeks using RSA and CT are performed as in group 1.

Study Type

Interventional

Enrollment (Anticipated)

35

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

  • Sweden
      • Linkoeping, Sweden, 58185
        • Recruiting
        • University Hospital Linkoeping
        • Contact:

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute Achilles Tendon rupture
  • Age between 18 and 60 years

Exclusion Criteria:

  • Previous rupture of either Achilles tendon
  • Diabetes mellitus
  • History of cancer
  • History of Rheumatoid disease
  • Treatment with steroids
  • Any counterindication for surgical treatment

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early weightbearing
Device: Early weightbearing
Patients in the intervention group are after 2 weeks supposed to remove the cast twice a day and use a special training pedal for 5 weeks (until cast removal).
EXPERIMENTAL: Control group
Device: Early weightbearing
Patients in the intervention group are after 2 weeks supposed to remove the cast twice a day and use a special training pedal for 5 weeks (until cast removal).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modulus of Elasticity
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

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

Sponsor

Linkoeping University

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

February 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (ESTIMATE)

February 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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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