Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing
Primary Purpose
Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early weightbearing
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles, Tendon, weightbearing
Eligibility 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
Sites / Locations
- University Hospital LinkoepingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early weightbearing
Control group
Arm Description
Outcomes
Primary Outcome Measures
Modulus of Elasticity
Secondary Outcome Measures
Full Information
NCT ID
NCT01063465
First Posted
February 4, 2010
Last Updated
February 4, 2010
Sponsor
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT01063465
Brief Title
Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing
Official Title
Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury
Keywords
Achilles, Tendon, weightbearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early weightbearing
Arm Type
Experimental
Arm Title
Control group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Early weightbearing
Intervention Description
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).
Primary Outcome Measure Information:
Title
Modulus of Elasticity
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten Schepull, M.D.
Phone
0046-13-224299
Email
thorsten.schepull@lio.se
First Name & Middle Initial & Last Name or Official Title & Degree
Per Aspenberg, M.D., PhD
Phone
0046-13-4166
Email
per.aspenberg@liu.se
Facility Information:
Facility Name
University Hospital Linkoeping
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Schepull, M.D.
Phone
0046-13-224299
Email
thorsten.schepull@lio.se
12. IPD Sharing Statement
Learn more about this trial
Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing
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