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Lack of funding
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This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. Patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the Tenex system. Both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leukocyte rich platelet rich plasma injection | Experimental | Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon |
|
| Percutaneous tenotomy | Experimental | Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukocyte rich platelet rich plasma | Biological | Leukocyte rich platelet rich plasma will be obtained and prepared from a peripheral artery of the subject and then will be injected in the common extensor tendon |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain: visual analogue scale | Change in pain will be measured using a 10 point visual analogue scale where 0 represents no pain and 10 indicates the worst pain possible. | up to 12 months post-procedure |
| Change in function | Change in function will be measured using the Oxford Elbow score using a 48 point scale where a score of 0 indicates severe functional impairment and a score of 48 indicates no functional impairment | up to 12 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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Non-blinded, parallel randomized control trial
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| Percutaneous Tenotomy | Device | Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device |
|
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |