Platelet Concentrate in Achilles Tendon Repair

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00537784

Enrollment

Registered

2007-10-01

Start date

2007-09-30

Completion date

2009-07-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury

Keywords

platelets tendon ligament

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.

Interventions

BIOLOGICALAutologous platelets

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

BIOLOGICALno injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Achilles tendon rupture, age 18-65.

Exclusion criteria

* Any counterindication for surgical treatment.

Design outcomes

Primary

Measure	Time frame
Modulus of elasticity	12 weeks

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026