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CompletedNCT00537784Updated Jun 19, 2013

Platelet Concentrate in Achilles Tendon Repair

An interventional study of Autologous platelets and no injection in Achilles Tendon Rupture, Soft Tissue Injury and Tendon Injury, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-19.

Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Achilles Tendon Rupture
  • Soft Tissue Injury
  • Tendon Injury

Keywords

  • platelets tendon ligament
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 30 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Achilles tendon rupture, age 18-65.

Exclusion criteria

Exclusion Criteria:

  • Any counterindication for surgical treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    1

    Injection of autologous platelet concentrate into repair site

    Biological: Autologous platelets

  • Placebo comparator
    2

    No injection

    Biological: no injection

Interventions

  • BiologicalAutologous platelets

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

  • Biologicalno injection
06

What researchers measure

Primary outcomes

  1. Modulus of elasticity

    Time frame: 12 weeks

07

Study locations

1 site
  • Univ Hosp
    Linköping, Se 88185, Sweden
08

References and documents

Publications

  • 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. Epub 2010 Nov 3. PubMed 21051425 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00537784
Lead sponsor
University Hospital, Linkoeping
Responsible party
Per Aspenberg (professor, University Hospital, Linkoeping) — Principal investigator
First posted
Oct 1, 2007
Start date
Sep 2007
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Jun 19, 2013

Study contacts

per aspenberg
principal investigator · University of Linköping

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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