Platelet Concentrate in Achilles Tendon Repair

Achilles Tendon Rupture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537784
• Other study ID #: Trombocytakilles
• Status: Completed
• Phase: N/A
• First received: September 28, 2007
• Last updated: June 17, 2013
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: June 2013
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Achilles tendon rupture, age 18-65.

Exclusion Criteria:

• Any counterindication for surgical treatment.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Soft Tissue Injuries
• Soft Tissue Injury
• Tendon Injuries
• Tendon Injury

Intervention

Biological:
• Autologous platelets
Local injection 10mL, about 2.5 x 10E10 platelets.
• no injection

Locations

Country	Name	City	State
Sweden	Univ Hosp	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Schepull T, Kvist J, Norrman H, Trinks M, Berlin G, Aspenberg P. Autologous platelets have no effect on the healing of human achilles tendon ruptures: a randomized single-blind study. Am J Sports Med. 2011 Jan;39(1):38-47. doi: 10.1177/0363546510383515. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulus of elasticity		12 weeks