Back to resultsPlatelet Concentrate in Achilles Tendon Repair
Primary Purpose
Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Autologous platelets
no injection
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring platelets tendon ligament
Eligibility Criteria
Inclusion Criteria:
- Achilles tendon rupture, age 18-65.
Exclusion Criteria:
- Any counterindication for surgical treatment.
Sites / Locations
- Univ Hosp
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Injection of autologous platelet concentrate into repair site
No injection
Outcomes
Primary Outcome Measures
Modulus of elasticity
Secondary Outcome Measures
Full Information
NCT ID
NCT00537784
First Posted
September 28, 2007
Last Updated
June 17, 2013
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT00537784
Brief Title
Platelet Concentrate in Achilles Tendon Repair
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury
Keywords
platelets tendon ligament
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Injection of autologous platelet concentrate into repair site
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
No injection
Intervention Type
Biological
Intervention Name(s)
Autologous platelets
Intervention Description
Local injection 10mL, about 2.5 x 10E10 platelets.
Intervention Type
Biological
Intervention Name(s)
no injection
Primary Outcome Measure Information:
Title
Modulus of elasticity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Achilles tendon rupture, age 18-65.
Exclusion Criteria:
Any counterindication for surgical treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
per aspenberg
Organizational Affiliation
University of Linköping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ Hosp
City
Linköping
ZIP/Postal Code
Se 88185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21051425
Citation
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.
Results Reference
result
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Platelet Concentrate in Achilles Tendon Repair
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