Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenex Procedure, Open Debridement Surgical Intervention Treatment Plan.
- Who it may be relevant to
- Registry conditions: Orthopedic Devices Associated With Misadventures. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.
Overview
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.
Detailed description
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.
Interventions
- Procedure Tenex 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. - Procedure Open Debridement Surgical Intervention Treatment Plan
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
Primary outcome measures
- The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation [Time frame: Study Enrollment Period]
Eligibility criteria
Inclusion criteria
- Individuals 18-70 years of age
- Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.
- Failed alternative treatment for > 3 months.
Exclusion criteria
- Surgical procedure on affected extremity within last six months.
- Dermatological disorder in affected area
- Currently pregnant, confirmed via pregnancy test.
- Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders.
- Failed prior surgical procedure on the affected joint.
- No prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 10 centers
- Virtua Reconstructive Orthopedics — Burlington
- Virtua Reconstructive Orthopedics — Cherry Hill
- Virtua Reconstructive Orthopedics — Moorestown
- Fellowship Surgical Center — Mount Laurel
- Surgical Center of South Jersey — Mount Laurel
- Virtua Reconstructive Orthopedics — Riverside Park
- Virtua Reconstructive Orthopedics — Sewell
- Centennial Surgery Center — Voorhees Township
- … and 2 more centers
Identifiers
NCT: NCT05757739 · G23004