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| Name | Class |
|---|---|
| Dr. Sean Mcmillan | UNKNOWN |
| Dr. Thomas Plut | UNKNOWN |
| Dr. Nathan Bodin | UNKNOWN |
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Lateral epicondylitis (Tennis Elbow) can cause pain and keep individuals from completing their daily activities and require them to miss work. There are currently different treatment options to address tennis elbow. However surgeons do not know if one is better than the other. This study will compare two treatment options for tennis elbow. Participants will either be treated by Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. Traditional open surgical debridement is a surgical procedure that requires the surgeon to make an incision to remove the damaged tissue. This procedure is done under anesthesia in a surgery center. In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.
During the initial screening visit, the physician will obtain your medical history and perform a physical exam. If you pass the screening, you will be randomized into either Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. It will be a 50% chance. It will be compared to flipping a coin.
Once you have been placed in your treatment group, your treatment will be scheduled. You will have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 6 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. You will also be requested to complete patient questionnaires about your progress at visits 3-7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenex Treatment Plan | Active Comparator |
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| Open Debridement Surgical Intervention Treatment Plan | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenex Procedure | Procedure | In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office. |
| Measure | Description | Time Frame |
|---|---|---|
| The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation | The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation | Study Enrollment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Hoopes | Contact | 856-355-1206 | dhoopes@virtua.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtua Reconstructive Orthopedics | Recruiting | Burlington | New Jersey | 08016 | United States |
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| Open Debridement Surgical Intervention Treatment Plan | Procedure | Operative treatment will be performed under anesthesia, and debridement of the extensor tendon's common origin will be performed with an open assessment of the tendon origin with tendon repair or reattachment |
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| Virtua Reconstructive Orthopedics | Recruiting | Cherry Hill | New Jersey | 08034 | United States |
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| Virtua Reconstructive Orthopedics | Recruiting | Moorestown | New Jersey | 08057-3128 | United States |
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| Fellowship Surgical Center | Recruiting | Mount Laurel | New Jersey | 08054 | United States |
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| Surgical Center of South Jersey | Recruiting | Mount Laurel | New Jersey | 08054 | United States |
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| Virtua Reconstructive Orthopedics | Recruiting | Riverside Park | New Jersey | 08075 | United States |
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| Virtua Reconstructive Orthopedics | Recruiting | Sewell | New Jersey | 08080 | United States |
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| Centennial Surgery Center | Recruiting | Voorhees Township | New Jersey | 08043 | United States |
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| Summit Surgical Center LLC | Recruiting | Voorhees Township | New Jersey | 08043 | United States |
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| Virtua Reconstructive Orthopedics | Recruiting | Voorhees Township | New Jersey | 08043 | United States |
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