Platelet Concentrate in Achilles Tendon Repair

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture; Soft Tissue Injury; Tendon Injury
• Interventions: Biological: Autologous platelets; Biological: no injection

• Registration Number: NCT00537784
• Lead Sponsor: University Hospital, Linkoeping

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

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-09-28
• Study First Posted: 2007-10-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Achilles tendon rupture, age 18-65.

Exclusion Criteria

• Any counterindication for surgical treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Autologous platelets	Injection of autologous platelet concentrate into repair site
2	no injection	No injection

Primary Outcome Measures

Name	Time	Method
Modulus of elasticity	12 weeks

Trial Locations

Locations (1)

Univ Hosp; 🇸🇪 Linköping, Sweden