Platelet Concentrate in Achilles Tendon Repair

University Hospital, Linkoeping

Status: Completed

Conditions: Achilles Tendon Rupture; Soft Tissue Injury; Tendon Injury

Treatments: Biological: Autologous platelets; Biological: no injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00537784

Trombocytakilles

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Achilles tendon rupture, age 18-65.

Exclusion criteria

• Any counterindication for surgical treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Injection of autologous platelet concentrate into repair site

Treatment:

Biological: Autologous platelets

2

Placebo Comparator group

Description:

No injection

Treatment:

Biological: no injection