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OpenTrials
Completed

NCT Number: NCT00537784

Platelet Concentrate in Achilles Tendon Repair

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ Hosp

Linköping, Se 88185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Achilles tendon rupture, age 18-65.

Exclusion criteria

  • Any counterindication for surgical treatment.

Treatment and study plan

Autologous platelets

Biological

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

no injection

Biological

Primary outcomes

  1. Modulus of elasticity

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 1, 2007
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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