Shoulder Surgery for Shoulder Injury

Recruiting at 3 trial locations

Overseen By Alexandre Lädermann, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: La Tour Hospital

Disqualifiers: Previous biceps tear, Infection, Non-compliance, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgical procedure

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat shoulder pain linked to the long head of the biceps tendon in individuals with rotator cuff issues. It compares three approaches: cutting and reattaching the tendon (LHB tenodesis), cutting it without reattaching (LHB tenotomy), or leaving it alone. The goal is to determine which method best reduces pain and improves shoulder function. Suitable participants have a full tear of a shoulder tendon and no prior bicep tear. As an unphased trial, this study provides a unique opportunity to contribute to understanding effective treatments for shoulder pain.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both LHB tenodesis and LHB tenotomy are generally safe for treating shoulder problems. Studies indicate that tenodesis remains safe even if repeated due to issues like attachment failure or shoulder pain. Most patients do not experience serious problems, though minor issues such as scarring or a biceps tear can occur.

Tenotomy is also considered safe with few complications. Known for its straightforward nature and quick recovery, some individuals might experience pain or cramping in the biceps afterward, though this is uncommon.

Both procedures aim to effectively relieve shoulder pain, with no significant difference in safety. Each offers its own advantages, but overall, patients tolerate both well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder injuries because they offer new approaches to managing the long head of the biceps (LHB). LHB Tenodesis involves cutting the LHB at its origin and reattaching it, potentially reducing pain and improving shoulder stability, which is different from more conservative treatments that leave the LHB intact. LHB Tenotomy, on the other hand, involves simply cutting the LHB at its origin, which may offer a quicker recovery and less post-operative pain compared to more invasive procedures. These options provide alternatives to the traditional approach of either leaving the LHB intact or undergoing more extensive reconstructive surgery, thus offering tailored solutions depending on the patient's specific needs and the nature of their shoulder injury.

What evidence suggests that this trial's treatments could be effective for shoulder injury?

In this trial, participants will join different treatment arms to evaluate the effectiveness of LHB tenodesis and tenotomy for issues with the long head of the biceps tendon. Research has shown that both LHB tenodesis and tenotomy effectively treat these problems. Studies have found no major difference in their ability to relieve pain or improve function. Participants in the LHB tenodesis arm may maintain better elbow strength and experience fewer visible changes in the arm's appearance compared to those in the LHB tenotomy arm. Conversely, participants undergoing tenotomy may benefit from quicker recovery and simpler rehabilitation with few complications. Both treatments significantly improve shoulder function, so the choice often depends on personal needs and lifestyle. ^{3 6 7 8 9}

Who Is on the Research Team?

Alexandre Lädermann, MD

Principal Investigator

La Tour Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with a full thickness tear of the supraspinatus tendon, an intact subscapularis tendon, and who are undergoing primary rotator cuff repair. Participants must be able to consent, complete questionnaires, attend follow-ups, and adhere to post-op therapy. Excluded are those with judgment impairments, language barriers, psychological disorders or dementia.

Inclusion Criteria

I agree to join the study and can follow the study plan, including filling out questionnaires and attending follow-up visits.

I have a complete tear in my shoulder tendon.

I am between 50 and 80 years old.

Exclusion Criteria

Enrolment of the investigator, his/her family members, employees and other dependent persons

Known or suspected non-compliance, drug or alcohol abuse

I am unable to make decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three surgical procedures: LHB tenodesis, LHB tenotomy, or leaving the LHB intact, in conjunction with rotator cuff repair.

Surgical procedure

Follow-up

Participants are monitored for post-operative functional outcomes and complications, with assessments at 6 and 24 months post-surgery.

24 months

Multiple visits for assessments at 6 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• LHB Tenodesis
• LHB Tenotomy

Trial Overview The study compares two procedures for shoulder pain associated with rotator cuff issues: LHB Tenotomy (cutting off the biceps tendon) and LHB Tenodesis (reattaching it). It aims to determine which leads to better outcomes—pain relief and function—or if leaving the tendon intact is just as effective.

How Is the Trial Designed?

Group I: LHB tenotomy Experimental Treatment 1 Intervention

The long head of the biceps (LHB) will be cut at its origin.

Group II: LHB Tenodesis Experimental Treatment 1 Intervention

The long head of the biceps (LHB) will be cut at its origin and reattached.

Group III: Leaving LHB Intact Active Control 1 Intervention

The long head of the biceps (LHB) will be left intact.

LHB Tenodesis is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Biceps Tenodesis for:

• Rotator cuff tears
• SLAP tears
• Biceps tendonitis
• Tendon instability

Approved in United States as Biceps Tenodesis for:

• Rotator cuff tears
• SLAP tears
• Biceps tendonitis
• Tendon instability

Approved in Canada as Biceps Tenodesis for:

• Rotator cuff tears
• SLAP tears
• Biceps tendonitis
• Tendon instability

Who Is Running the Clinical Trial?

La Tour Hospital

Lead Sponsor

Trials

16

Recruited

246,000+

Published Research Related to This Trial

The all-arthroscopic biceps tenodesis technique, which secures the tendon in the suprapectoral region, demonstrated biomechanical strength comparable to the traditional mini-open subpectoral method, with no significant differences in load to failure or displacement.

In a clinical evaluation of 49 patients, the all-arthroscopic technique resulted in significant improvements in shoulder function, with a mean ASES score increase from 65.4 preoperatively to 87.1 post-surgery, and a high satisfaction rate of 94.1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Biomechanical Evaluation of an All-Arthroscopic Suprapectoral Biceps Tenodesis. Kahlenberg, CA., Patel, RM., Nair, R., et al.[2020]

Open subpectoral tenodesis is an effective surgical treatment for long head of the biceps tendon pathology, providing consistent pain relief and reliable fixation.

This technique not only prevents cosmetic deformity and cramping during activity but also restores the proper length-tension relationship of the biceps muscle by removing diseased tendon tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open subpectoral biceps tenodesis: reliable treatment for all biceps tendon pathology. Kane, P., Hsaio, P., Tucker, B., et al.[2018]

In a study of 34 patients with long head of the biceps tendinopathy, biceps tenotomy provided quicker pain relief compared to tenodesis, with 75% of tenotomy patients reporting no pain medication use at 2 weeks post-surgery.

However, while both surgical options showed similar long-term outcomes after 2 years, the tenotomy group had a higher incidence of cosmetic deformity (25% reported 'Popeye deformity') compared to only 7% in the tenodesis group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biceps tenotomy has earlier pain relief compared to biceps tenodesis: a randomized prospective study. Belay, ES., Wittstein, JR., Garrigues, GE., et al.[2020]

Biceps tenodesis results in a significantly lower rate of cosmetic deformity (6.8%) compared to biceps tenotomy (23.3%), making it a more favorable option for patients concerned about appearance after surgery.

Both surgical options, tenodesis and tenotomy, provide similar improvements in pain and function for patients with long head of the biceps tendon pathology, with only minor differences in strength outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biceps tenodesis versus tenotomy: a systematic review and meta-analysis of level I randomized controlled trials. Belk, JW., Kraeutler, MJ., Houck, DA., et al.[2021]

In a meta-analysis of 9 randomized controlled trials involving surgical treatments for long head of the biceps tendon (LHBT) lesions, tenotomy was found to be more time-efficient than tenodesis, with a significant difference in operative time.

While tenodesis showed a slight advantage in the Constant score and a lower risk of developing the 'Popeye deformity', there were no significant differences in other outcomes like pain levels or muscle strength, suggesting that tenotomy may be a viable option despite its cosmetic drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biceps tenotomy versus tenodesis for lesions of the long head of the biceps tendon: A systematic review and meta-analysis of randomized controlled trials. Zhou, P., Liu, J., Deng, X., et al.[2021]

Laterally eccentric placement of the biceps tenodesis screw significantly reduces humeral strength by an average of 25%, increasing the risk of humeral fractures post-surgery, while centrally placed screws do not show a significant reduction in strength.

The study emphasizes the importance of proper surgical technique, particularly central screw positioning, to minimize complications, especially in patients with smaller humeral widths or those engaged in high-impact activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical analysis of subpectoral biceps tenodesis: effect of screw malpositioning on proximal humeral strength. Euler, SA., Smith, SD., Williams, BT., et al.[2018]

In a study of 11 active patients with long head of the biceps (LHB) deformity after failed tenotomy or auto-rupture, 90% returned to full activity following mini-open subpectoral biceps tenodesis, indicating a high success rate for this surgical intervention.

Patient-reported outcomes showed significant improvements post-surgery, with SANE scores increasing from 61.1 to 84.2 and WORC scores from 53.2 to 86, while deformity and cramping were resolved in all patients, demonstrating the efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biceps tenodesis for long head of the biceps after auto-rupture or failed surgical tenotomy: results in an active population. Anthony, SG., McCormick, F., Gross, DJ., et al.[2018]

In a study of 252 patients, those who underwent simple tenotomy for long head biceps lesions showed better post-operative outcomes, including less pain and improved shoulder function, compared to those who had tenodesis.

The tenotomy procedure was deemed the preferred treatment option for rotator cuff repairs involving LHB lesions, despite the presence of the 'Popeye sign' being poorly perceived by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of three surgical procedures for long head biceps tendinopathy associated with rotator cuff tears. Biz, C., Vinanti, GB., Rossato, A., et al.[2021]

Biceps tenodesis procedures have increased significantly in the last decade, likely due to concerns about cosmetic deformity and pain associated with biceps tenotomy, despite limited evidence showing that tenodesis offers better functional outcomes.

Current research primarily addresses long head of the biceps (LHB) disorders in conjunction with rotator cuff tears, highlighting a need for more studies focused on LHB disorders without such tears to better understand the effectiveness of tenodesis versus tenotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biceps tenodesis versus biceps tenotomy for biceps tendinitis without rotator cuff tears. Hassan, S., Patel, V.[2020]

The long head of the biceps (LHB) tendon is a common source of shoulder pain, often associated with other injuries, and can be treated effectively with tenodesis, a surgical technique that stabilizes the tendon.

The described arthroscopic onlay articular margin biceps tenodesis technique offers strong fixation and preserves the tendon’s natural length-tension relationship, which is crucial for maintaining shoulder function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Onlay Articular Margin Biceps Tenodesis for Long Head of the Biceps Tendon Pathology. Cagle, PJ., Zastrow, RK., Chan, JJ., et al.[2020]

Surgical options like tenotomy or tenodesis of the long head of biceps tendon (LHBT) are effective for relieving anterior shoulder pain caused by LHBT issues.

However, tenotomy can lead to common adverse effects such as cosmetic deformity, muscle cramping, and strength deficits, while tenodesis carries risks like fixation loss, infection, and neurologic injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Proximal Biceps Tenotomy and Tenodesis. Virk, MS., Nicholson, GP.[2022]

The Needle-Anchor arthroscopic tenodesis technique for treating isolated long head of the biceps tendon disorders showed significant improvements in shoulder function and pain relief, with Constant-Murley scores increasing from 55.14 to 88.90 and VAS pain scores decreasing from 5.34 to 0.58 after 12 months.

This technique was found to be reliable, safe, and time-efficient, making it a promising option for patients with LHB tendon disorders, as evidenced by the positive outcomes in a study of 60 patients over a follow-up period of 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our Totally Intra-Articular "Needle-Anchor" Tenodesis Technique Applied in Isolated Long Head of the Biceps Tendinopathy: Clinical and Functional Results in 60 Patients. Vitali, M., Pedretti, A., Naim Rodriguez, N., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9557260/

Clinical effectiveness of tenotomy versus tenodesis for long ... This study found no significant difference in functional scores (ASES, Constant and SANE), ROM, pain or complication rates between these groups.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806321004564

Clinical Outcomes of Revision Biceps Tenodesis for Failed ... Bicipital pain, cramping, and rerupture were shown to be the most common reasons for revision tenodesis, while adhesions, fixation failure, and rerupture were ...

3. cureus.com cureus.com/articles/118525-clinical-outcomes-of-long-head-biceps-tendinitis-treatment-by-a-semitenodesis-technique

Clinical Outcomes of Long Head Biceps Tendinitis ... Additionally, the near absence of pain (96% improvement) was achieved at three months postoperatively in our study, while the same postoperative ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324000677

Rotator Cuff Biceps tenotomy vs. tenodesis in patients ... When comparing the tenotomy and tenodesis cohorts, tenotomy patients were found to have increased AROM at 3 months in forward flexion (153.2° vs. 130.1°, P = .

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4794538/

Outcomes of tenodesis of the long head of the biceps ... RESULTS: Tenodesis with an interference screw was possible in all patients more than 3 mo after rupture and 90% had good to excellent outcomes but two had ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/10/e061954

Clinical effectiveness of tenotomy versus tenodesis for long ... Aside from a lower rate of cosmetic deformity, tenodesis yielded no significant clinical benefit to tenotomy for addressing LHB pathology.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5127942/

Outcomes following long head of biceps tendon tenodesis For patients with fixation failure or continued anterior shoulder pain, revision LHB tenodesis is safe and effective. Heckman et al. [69] ...

8. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00017-2/fulltext

Shoulder Biceps Tenodesis Versus Tenotomy: Both Show ... It is a retrospective review study of 110 patients who underwent biceps tenodesis due to a long head biceps (LHB) injury and in the absence of other rotator ...

9. mdpi.com mdpi.com/2077-0383/14/3/852

Both Isolated Long Head of the Biceps Tenotomy and ... This study demonstrated that both isolated tenotomy and tenodesis are effective and safe in treating patients with a symptomatic shoulder after rotator cuff ...