Platelet Concentrate in Achilles Tendon Repair

This study is ongoing, but not recruiting participants.

First Received: September 28, 2007 Last Updated: October 3, 2008 History of Changes

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

No publications provided

Study ID Numbers:	Trombocytakilles
Study First Received:	September 28, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00537784 History of Changes
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

Additional relevant MeSH terms:

Tendon Injuries
Soft Tissue Injuries
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 06, 2009