Tennis ElbowPhase 4NCT03718637
Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
A Phase 4 study testing Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy and Ultrasound Imaging in people with Tennis Elbow and Lateral Epicondylitis, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis
- What is being tested?
- Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy and Ultrasound Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 17 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Who cannot join
- Previous surgery on the currently-affected elbow.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Johnny Kasto, MD, 3132448078, jkasto1@hfhs.org
Stephanie J Muh, MD
About this study
Official title: Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
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.
Read the detailed description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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.
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Being tested
- Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy, Ultrasound Imaging
- Keywords
- Tennis Elbow, Tendinopathy, Lateral Epicondylitis, Bioinductive
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smith & Nephew Bioinductive ImplantBiological
Also called Bioinductive Patch
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
Lateral EpicondylectomyProcedure or surgery
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
Ultrasound ImagingRadiation
An ultrasound will be performed on each patient both preoperatively and at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively. Receives: Procedure: Lateral Epicondylectomy; Radiation: Ultrasound Imaging |
| Experimental | Experimental | Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. Receives: Biological: Smith & Nephew Bioinductive Implant; Procedure: Lateral Epicondylectomy; Radiation: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS CAT Scores
A short 5 minute survey asking questions about physical function, pain, and mental health
Measured: Preoperative to 1 year postoperative
Visual Analog Scale (VAS) for Pain
Traditional 1 to 10, subjective rating of pain the patient is experiencing
Measured: Preoperative to 1 year postoperative
Range of Motion
Standard range of motion values collected by the surgeon during preoperative and followup visits
Measured: Preoperative to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start17 Apr 2019
- Primary completion17 May 2026 (estimated)
- Study completion17 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Stephanie Muh, MD, Henry Ford Health System
- Investigators
- Stephanie J Muh, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718637
- Sponsor's protocol ID
- 12495
- Status last verified
- Mar 2025
- First submitted
- 23 Oct 2018
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
- ClinicalTrials.gov ID
- NCT03718637
- Acronym / sponsor ID
- 12495
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Keywords
- Tennis Elbow, Tendinopathy, Lateral Epicondylitis, Bioinductive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 17 May 2026 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Lateral Epicondylectomy, Radiation: Ultrasound ImagingSurgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively. |
| Experimental | Experimental | Biological: Smith & Nephew Bioinductive Implant, Procedure: Lateral Epicondylectomy, Radiation: Ultrasound ImagingIdentical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
Key exclusion criteria (1 listed)
- Previous surgery on the currently-affected elbow.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smith & Nephew Bioinductive ImplantAlso: Bioinductive PatchA bioinductive implant that is supposed to foster healthy tendon regrowth after surgery. | Biological | Experimental |
| Lateral EpicondylectomyThis procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options. | Procedure or surgery | Control, Experimental |
| Ultrasound ImagingAn ultrasound will be performed on each patient both preoperatively and at 6 months. | Radiation | Control, Experimental |
Primary outcome
PROMIS CAT Scores
Time frame: Preoperative to 1 year postoperative
A short 5 minute survey asking questions about physical function, pain, and mental health
Visual Analog Scale (VAS) for Pain
Time frame: Preoperative to 1 year postoperative
Traditional 1 to 10, subjective rating of pain the patient is experiencing
Range of Motion
Time frame: Preoperative to 1 year
Standard range of motion values collected by the surgeon during preoperative and followup visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
Related trials for Tennis Elbow
Not yet recruitingObservational study
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Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
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Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie J Muh, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy and Ultrasound Imaging in people with Tennis Elbow and Lateral Epicondylitis, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johnny Kasto, MD (3132448078, jkasto1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS CAT Scores (time frame: Preoperative to 1 year postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.