Platelet Concentrate in Achilles Tendon Repair - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 28, 2007

Last Updated Date

October 3, 2008

Start Date ^†

September 2007

Current Primary Outcome Measures ^†

Modulus of elasticity [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537784 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Platelet Concentrate in Achilles Tendon Repair

Official Title ^†

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Condition ^†

Achilles Tendon Rupture
Soft Tissue Injury
Tendon Injury

Intervention ^†

Biological: Autologous platelets
Biological: no injection

Study Arms / Comparison Groups

Active Comparator: Injection of autologous platelet concentrate into repair site
Placebo Comparator: No injection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Achilles tendon rupture, age 18-65.

Exclusion Criteria:

Any counterindication for surgical treatment.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537784

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Linkoeping

Collaborators ^††

Investigators ^†

Principal Investigator:

per aspenberg

University of Linköping

Information Provided By

University Hospital, Linkoeping

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.