Platelet Concentrate in Achilles Tendon Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00537784
First received: September 28, 2007
Last updated: June 17, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by University Hospital, Linkoeping:

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

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00537784     History of Changes
Other Study ID Numbers: Trombocytakilles
Study First Received: September 28, 2007
Last Updated: June 17, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
platelets tendon ligament

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

ClinicalTrials.gov processed this record on October 22, 2014