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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Linkoeping University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01063465
First received: February 4, 2010
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Achilles Tendon Rupture
Soft Tissue Injury
Tendon Injury
Device: Early weightbearing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Modulus of Elasticity [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: February 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063465

Contacts
Contact: Thorsten Schepull, M.D. 0046-13-224299 thorsten.schepull@lio.se
Contact: Per Aspenberg, M.D., PhD 0046-13-4166 per.aspenberg@liu.se

Locations
Sweden
University Hospital Linkoeping Recruiting
Linkoeping, Sweden, 58185
Contact: Thorsten Schepull, M.D.    0046-13-224299    thorsten.schepull@lio.se   
Sponsors and Collaborators
Linkoeping University
  More Information

No publications provided

Responsible Party: Thorsten Schepull, M.D., Orthopaedic department, University Hospital Linkoeping, Sweden
ClinicalTrials.gov Identifier: NCT01063465     History of Changes
Other Study ID Numbers: 001
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Achilles
Tendon
weightbearing

Additional relevant MeSH terms:
Soft Tissue Injuries
Tendon Injuries
Wounds and Injuries
Rupture

ClinicalTrials.gov processed this record on August 28, 2014