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Platelet Concentrate in Achilles Tendon Repair

NCT00537784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-06-19

No results posted yet for this study

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

BIOLOGICAL

Autologous platelets

Local injection 10mL, about 2.5 x 10E10 platelets.

BIOLOGICAL

no injection

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • per aspenberg · University of Linköping

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537784 on ClinicalTrials.gov