Bioinductive Implant for Tennis Elbow

Overseen By Johnny Kasto, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Henry Ford Health System

Disqualifiers: Previous elbow surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Immediate (surgery)

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special bioinductive patch, the Smith & Nephew Bioinductive Implant, can heal tennis elbow more effectively than surgery alone. Tennis elbow causes pain around the elbow due to overuse, and this patch may aid tendon regrowth and recovery. Participants will undergo either their usual surgery or the same surgery with the addition of the patch. The trial targets individuals who have tried physical therapy and other treatments but still experience tennis elbow. Those who have previously had surgery on the affected elbow are not eligible for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Smith & Nephew Bioinductive Implant?

Research shows that bioinductive implants, like the one used in this trial, have been safely used for other conditions, such as rotator cuff tears. Studies have demonstrated that these implants work well and result in fewer complications compared to standard treatments alone. For example, one study found that the risk of a re-tear was three times lower with the bioinductive implant than with standard repair methods, suggesting that the implant is generally well-tolerated by patients.

However, occasional reports of side effects exist. In one case, a patient experienced increased pain after surgery with the implant and required another surgery. Despite these rare instances, the overall safety record remains positive. The FDA has approved the implant, indicating a strong safety profile based on previous research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard surgical care for tennis elbow, which involves tendon debridement and repair, the Smith & Nephew bioinductive implant adds an innovative twist. This bio-inductive patch is designed to stimulate the body's natural healing process, potentially enhancing tendon regeneration and reducing recovery time. Researchers are excited because this implant could lead to faster, more effective healing compared to traditional surgery alone, offering hope for improved outcomes in patients suffering from this often stubborn condition.

What evidence suggests that the Smith & Nephew Bioinductive Implant is effective for tennis elbow?

Research has shown that the Smith & Nephew Bioinductive Implant effectively reduces tendon damage. In earlier studies, the implant reduced re-tear rates by 65% in similar shoulder conditions. Another study found it lowered the risk of re-tearing by three times compared to standard repair alone. These results suggest that the implant helps the tendon heal better and remain stronger. The FDA has approved the implant, indicating its proven effectiveness for certain conditions. In this trial, participants in the experimental arm will receive the Smith & Nephew Bioinductive Implant in addition to surgical treatment, while the control arm will receive surgical treatment alone. Although this study focuses on tennis elbow, these findings are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephanie J Muh, MD

Principal Investigator

Henry Ford Health System

Are You a Good Fit for This Trial?

This trial is for individuals with tennis elbow that hasn't improved after physical therapy, lifestyle changes, and anti-inflammatory treatments. It's not open to those who've had previous surgery on the affected elbow.

Inclusion Criteria

My tennis elbow didn't improve with standard treatments like physical therapy.

Exclusion Criteria

I have had surgery on my affected elbow before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical treatment with or without the bioinductive patch implant

Immediate (surgery)

1 visit (in-person, surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment using ultrasound and other measures

1 year

Multiple visits (in-person) including preoperative and 6 months postoperative

What Are the Treatments Tested in This Trial?

Interventions

• Smith & Nephew Bioinductive Implant

Trial Overview The study compares traditional surgery for tennis elbow against the same surgery plus a new FDA-approved bioinductive patch designed to promote tendon healing. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 3 Interventions

Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.

Group II: Control Active Control 2 Interventions

Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.

Smith & Nephew Bioinductive Implant is already approved in United States, European Union, Japan for the following indications:

Approved in United States as REGENETEN Bioinductive Implant for:

• Management and protection of tendon injuries in which there has been no substantial loss of tendon tissue

Approved in European Union as REGENETEN Bioinductive Implant for:

• Management and protection of tendon injuries in which there has been no substantial loss of tendon tissue

Approved in Japan as REGENETEN Bioinductive Implant for:

• Management and protection of tendon injuries in which there has been no substantial loss of tendon tissue

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

In a study of 52 patients with chronic lateral epicondylitis, both autologous conditioned plasma (ACP) injections and low-level laser therapy resulted in significant clinical improvements, with 63.5% of patients achieving successful treatment outcomes after one year.

ACP therapy is highlighted as a promising and easy-to-apply alternative treatment option for lateral epicondylitis, showing comparable efficacy to laser therapy in improving pain and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous proliferative therapies in recalcitrant lateral epicondylitis. Tetschke, E., Rudolf, M., Lohmann, CH., et al.[2016]

Collagen bioinductive implant augmentation was successfully used to treat two cases of chronic lower extremity tendinopathies, showing promise as an effective surgical strategy.

Both patients, a 20-year-old male football player and a 40-year-old active female, were able to return to their pre-injury activity levels more quickly after the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioinductive Collagen Implant Augmentation for the Repair of Chronic Lower Extremity Tendinopathies: A Report of Two Cases. Looney, AM., Fortier, LM., Leider, JD., et al.[2021]

In a study of 120 patients with tennis elbow, those receiving local injections of allogeneic platelet-derived growth factors showed a significant reduction in pain and improved function, with 85% reporting excellent outcomes compared to only 8% in the control group receiving saline.

The treatment group also reported a high satisfaction rate of 95%, indicating that allogeneic growth factors could be a safe and effective option for managing tennis elbow, although further research is needed to confirm the long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic platelet-derived growth factors local injection in treatment of tennis elbow: a prospective randomized controlled study. Kandil, MI., Ahmed, AA., Eldesouky, RS., et al.[2022]

Total elbow arthroplasty is indicated for patients with severe elbow joint damage, while contraindications include active infections and inadequate bone support.

The authors present a clinical case using the Coonrad-Morrey implant, highlighting its application in total elbow replacement procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total elbow arthroplasty]. Pomianowski, S., Rylski, W., Sawicki, G., et al.[2014]

The BioBrace™ is a novel bio-inductive scaffold designed for rotator cuff augmentation, combining the benefits of tissue induction and structural strength, which addresses the limitations of existing treatments.

This innovative implant uses a unique composition of type I collagen and bio-resorbable microfilaments, aiming to enhance tissue incorporation while providing immediate support during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. Cheesman, QT., Szukics, PF., Stark, M., et al.[2022]

Elbow replacement arthroplasty is now a standard treatment for various elbow diseases, including trauma, with long-term outcomes showing about 90% survival rates at 10 years, similar to other joint replacements.

Common complications associated with elbow implants include infection, aseptic loosening, and prosthetic failure, highlighting the importance of monitoring patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of elbow replacement arthroplasty. Roth, E., Chew, FS.[2022]

In a study of 36 patients who received the Acclaim total elbow replacement, the implant showed promising short-term results with significant pain relief and improved movement and function after a mean follow-up of 36 months.

Despite the positive outcomes, 30.5% of patients experienced intra-operative fractures of the humeral condyle, although this did not significantly impact overall results, leading to a redesign of the surgical guide to mitigate this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results of the Acclaim elbow replacement. Bassi, RS., Simmons, D., Ali, F., et al.[2019]

In a study of 70 patients undergoing Coonrad-Morrey total elbow arthroplasty, rheumatoid arthritis patients showed significantly better outcomes (mean Mayo Elbow Performance Score of 89) compared to those with traumatic conditions (mean score of 80) after an average follow-up of 5 years.

The survival rate of the implant was high, at 97.7% at 5 years and 91.0% at 10 years, although complications were common, with 27 reported cases and 9 requiring revision surgery, raising concerns about radiolucencies and bushing wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with the Coonrad-Morrey total elbow arthroplasty: 78 consecutive total elbow arthroplasties reviewed with an average 5 years of follow-up. Mansat, P., Bonnevialle, N., Rongières, M., et al.[2022]

A novel technique using a bio-inductive implant is proposed for treating insertional patellar tendinopathies and symptomatic partial tears, which could offer a new option for athletes suffering from this condition.

Most current treatments for patellar tendinopathies are non-surgical, and when surgery is needed, traditional methods involve open debridement or tendon repair, highlighting the potential benefits of this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of an Insertional High Grade Partial Patellar Tendon Tear Utilizing a Bio-Inductive Implant. Mc Millan, S., Faoao, DO., Ford, E.[2020]

In a study involving 210 patients undergoing arthroscopic repair of full-thickness rotator cuff tears, the use of a resorbable bioinductive bovine collagen implant led to significant improvements in shoulder function and quality of life measures after one year, regardless of the size of the tear.

The study reported a 10.4% rate of serious complications, including revision surgeries and other issues, indicating that while the implant is effective, there are risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry. McIntyre, LF., McMillan, S., Trenhaile, SW., et al.[2022]

In a study of 126 patients with resistant lateral tennis elbow, a quick surgical technique involving the desinsertion of epicondylar muscles led to successful outcomes in 112 cases, indicating a high efficacy of the procedure.

The best results were observed in younger patients and athletes with early-stage lesions, suggesting that early intervention may improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of refractory tennis elbow. Apropos of 126 cases]. Saillant, G., Edouard, B., Benazet, JP., et al.[2009]

The Discovery Elbow System is designed to closely match natural elbow movement and preserve important ligaments, which helps improve the function and comfort of the joint after replacement.

Elbow replacements generally provide a reliable restoration of pain-free motion, especially in low-demand patients, but the decision to use this system should consider the patient's age and activity level for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally constrained elbow implant arthroplasty: the discovery elbow system. Hastings, H.[2022]

The bioinductive collagen implant used for treating partial- and full-thickness rotator cuff tears demonstrated significant safety and efficacy, with patients showing marked improvements in pain and function at 1-year follow-up, as measured by various standardized outcomes.

In the study involving patients with rotator cuff tears, 84% of those with partial tears and 72% of those with full-thickness tears reported clinically meaningful improvements in pain and shoulder function, indicating the implant's effectiveness in promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. McIntyre, LF., Bishai, SK., Brown, PB., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-4-tennis-elbow-3-2019-48cd5

Bioinductive Implant for Tennis Elbow The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch ...

2. smith-nephew.com smith-nephew.com/en/news/2025/09/11/20250911-sn-unveils-major-clinical-evidence-and-patient-access-updates

Smith+Nephew unveils major clinical evidence and patient ... Two-year results of the MALLAMANGUITO RCT from Dr. Miguel A. Ruiz Ibán and colleagues demonstrated a sustained 65% relative reduction in re-tear ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03718637/efficacy-bioinductive-implant-for-tennis-elbow-lateral-epicondylitis

Efficacy Bioinductive Implant for Tennis Elbow (Lateral ... The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients.

4. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/sports-medicine/regeneten-bioinductive-implant

REGENETEN Bioinductive Implant | Smith+Nephew USA 3x reduction in re-tear risk in a randomized controlled trial versus standard repair alone in medium-to-large full-thickness tears (8.3% vs 25.8% at 1 year; ...

5. smith-nephew.com smith-nephew.com/en-us/blogs/2025/03/18/new-study-on-regeneten-bioinductive-implant

New study on REGENETEN◊ Bioinductive Implant New study confirms Smith+Nephew's REGENETEN◊ Bioinductive Implant reduces full-thickness rotator cuff re-tear rates¹ by 68%.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=15710010&pc=OWY

MAUDE Adverse Event Report: SMITH & NEPHEW, INC ... It was reported that after an acl, in which a regeneten bioinductive device was implanted, the patient experienced more pain.A revision surgery is planned ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11848954/

The bioinductive collagen implant yields positive histological ... The aim of this study is to report and discuss the outcomes of clinical, histological and animal studies exploring the application of bio‐inductive collagen ...