NCT00537784

Platelet Concentrate in Achilles Tendon Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achilles Tendon Rupture
• Soft Tissue Injury
• Tendon Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous platelets	Local injection 10mL, about 2.5 x 10E10 platelets.
BIOLOGICAL	no injection

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-10-01
• Last updated: 2013-06-19

Locations

1 site across 1 country: Sweden