Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing
NCT ID: NCT01063465
Last Updated: 2010-02-05
Study Results
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Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles tendon.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early weightbearing
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).
Control group
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 60 years
Exclusion Criteria
* Diabetes mellitus
* History of cancer
* History of Rheumatoid disease
* Treatment with steroids
* Any counterindication for surgical treatment
18 Years
60 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Orthopaedic department, University Hospital Linkoeping, Sweden
Locations
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University Hospital Linkoeping
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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