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Platelet Concentrate in Achilles Tendon Repair
This study is ongoing, but not recruiting participants.
Sponsored by: University Hospital, Linkoeping
Information provided by: University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00537784
  Purpose

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

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Modulus of elasticity [ Time Frame: 12 weeks ]

Estimated Enrollment: 2
Study Start Date: September 2007
Arms Assigned Interventions
1: Active Comparator
Injection of autologous platelet concentrate into repair site
Biological: Autologous platelets
Local injection 10mL, about 2.5 x 10E10 platelets.
2: Placebo Comparator
No injection
Biological: no injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achilles tendon rupture, age 18-65.

Exclusion Criteria:

  • Any counterindication for surgical treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537784

Locations
Sweden
Univ Hosp
Linköping, Sweden, Se 88185
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: per aspenberg University of Linköping
  More Information

Study ID Numbers: Trombocytakilles
Study First Received: September 28, 2007
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00537784  
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
platelets tendon ligament

Study placed in the following topic categories:
Tendon Injuries
Soft Tissue Injuries
Wounds and Injuries
Disorders of Environmental Origin
Rupture

ClinicalTrials.gov processed this record on January 15, 2009