NCT00537784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

September 28, 2007

Last Update Submit

June 17, 2013

Conditions

Achilles Tendon RuptureSoft Tissue InjuryTendon Injury

Keywords

platelets tendon ligament

Outcome Measures

Primary Outcomes (1)

  • Modulus of elasticity

    12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Injection of autologous platelet concentrate into repair site

Biological: Autologous platelets

2

PLACEBO COMPARATOR

No injection

Biological: no injection

Interventions

Autologous plateletsBIOLOGICAL

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

1
no injectionBIOLOGICAL
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Achilles tendon rupture, age 18-65.

You may not qualify if:

  • Any counterindication for surgical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ Hosp

Linköping, Se 88185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21051425RESULT

MeSH Terms

Conditions

Soft Tissue InjuriesTendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • per aspenberg

    University of Linköping

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 28, 2007

First Posted

October 1, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

SE(1)