Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT03718637
Phase
PHASE4
Status
Recruiting
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Conditions

  • Lateral Epicondylitis
  • Tennis Elbow

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Smith & Nephew Bioinductive Implant — BIOLOGICAL
    A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
  • Lateral Epicondylectomy — PROCEDURE
    This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
  • Ultrasound Imaging — RADIATION
    An ultrasound will be performed on each patient both preoperatively and at 6 months.

Study Details

The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Key Dates

Start date
Apr 17, 2019
Status verified
Mar 2025
Primary completion
May 17, 2026
Completion
Jan 17, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
  • Experimental: Experimental
    Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.

Primary Outcome Measure

PROMIS CAT Scores [ Time Frame: Preoperative to 1 year postoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202
Johnny Kasto, MD
[email protected]
3132448078
Stephanie J Muh, MD (PRINCIPAL_INVESTIGATOR)
Eric C Makhni, MD (SUB_INVESTIGATOR)
Vasilios Moutzouros, MD (SUB_INVESTIGATOR)
Elizabeth King, MD (SUB_INVESTIGATOR)

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By research site
Henry Ford Hospital· Detroit, MI

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