Platelet Concentrate in Achilles Tendon Repair

• Sponsor: University Hospital, Linkoeping (Other)
• Overall Status: Completed
• CT.gov ID: NCT00537784
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture; Soft Tissue Injury; Tendon Injury	Biological: Autologous platelets; Biological: no injection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Modulus of elasticity [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Achilles tendon rupture, age 18-65.

Exclusion Criteria:

• Any counterindication for surgical treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ Hosp	Linköping		Sweden	Se 88185

Sponsors and Collaborators

• University Hospital, Linkoeping

Investigators

• Principal Investigator: per aspenberg, University of Linköping

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
• ClinicalTrials.gov Identifier: NCT00537784
• Other Study ID Numbers: Trombocytakilles
• First Posted: Oct 1, 2007
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Per Aspenberg, professor, University Hospital, Linkoeping: platelets tendon ligament
• Additional relevant MeSH terms: Wounds and Injuries; Rupture; Tendon Injuries; Soft Tissue Injuries

Study Results

No Results Posted as of Jun 19, 2013