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?

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.

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.

Is the Bioinductive Implant safe for use in humans?

Research shows that bioinductive implants, like the resorbable bovine collagen implant, have been safely used in humans for conditions like rotator cuff tears and tendinopathies, with studies reporting positive safety outcomes. ^{1 2 3 4 5}

How does the Smith & Nephew Bioinductive Implant treatment for tennis elbow differ from other treatments?

The Smith & Nephew Bioinductive Implant is unique because it uses a bioinductive material to encourage the body's natural healing process, potentially offering a less invasive alternative to traditional surgical options like elbow replacement, which involves replacing joint surfaces with metal and plastic components. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Smith & Nephew Bioinductive Implant for tennis elbow?

The use of bio-inductive implants, like the Smith & Nephew Bioinductive Implant, has shown promise in other conditions such as rotator cuff repair, where they help in new tissue formation. This suggests potential benefits for tissue healing in tennis elbow as well. ^{1 2 11 12 13}

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Autologous proliferative therapies in recalcitrant lateral epicondylitis. [2016]

2. France pubmed.ncbi.nlm.nih.gov

[Surgical treatment of refractory tennis elbow. Apropos of 126 cases]. [2009]

3. Iran pubmed.ncbi.nlm.nih.gov

Treatment of an Insertional High Grade Partial Patellar Tendon Tear Utilizing a Bio-Inductive Implant. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Rotator Cuff Repair Technique Using a Bio-Composite Scaffold for Tissue Augmentation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Allogeneic platelet-derived growth factors local injection in treatment of tennis elbow: a prospective randomized controlled study. [2022]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Bioinductive Collagen Implant Augmentation for the Repair of Chronic Lower Extremity Tendinopathies: A Report of Two Cases. [2021]

9. Poland pubmed.ncbi.nlm.nih.gov

[Total elbow arthroplasty]. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Early results of the Acclaim elbow replacement. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Imaging of elbow replacement arthroplasty. [2022]

13. United States 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. [2022]