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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Injection of autologous platelet concentrate into repair site |
|
| 2 | Placebo Comparator | No injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous platelets | Biological | Local injection 10mL, about 2.5 x 10E10 platelets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Modulus of elasticity | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| per aspenberg | University of Linköping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ Hosp | Linköping | Se 88185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21051425 | Result | 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. |
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| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| D013708 | Tendon Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| no injection |
| Biological |
|