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Platelet Concentrate in Achilles Tendon Repair

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ClinicalTrials.gov Identifier: NCT00537784
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Achilles Tendon Rupture Soft Tissue Injury Tendon Injury Biological: Autologous platelets Biological: no injection

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Injection of autologous platelet concentrate into repair site
Biological: Autologous platelets
Local injection 10mL, about 2.5 x 10E10 platelets.
Placebo Comparator: 2
No injection
Biological: no injection


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achilles tendon rupture, age 18-65.

Exclusion Criteria:

  • Any counterindication for surgical treatment.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00537784     History of Changes
Other Study ID Numbers: Trombocytakilles
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Per Aspenberg, University Hospital, Linkoeping:
platelets tendon ligament

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