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Sponsored by: |
University Hospital, Linkoeping |
Information provided by: | University Hospital, Linkoeping |
ClinicalTrials.gov Identifier: | NCT00537784 |
People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.
Condition | Intervention |
Achilles Tendon Rupture Soft Tissue Injury Tendon Injury |
Biological: Autologous platelets Biological: no injection |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
Estimated Enrollment: | 2 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
1: Active Comparator
Injection of autologous platelet concentrate into repair site
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Biological: Autologous platelets
Local injection 10mL, about 2.5 x 10E10 platelets.
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2: Placebo Comparator
No injection
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Biological: no injection |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Trombocytakilles |
First Received: | September 28, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00537784 |
Health Authority: | Sweden: Regional Ethical Review Board |
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