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?

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.

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 shoulder surgery for shoulder injury, specifically involving biceps tenotomy or tenodesis, generally safe?

Biceps tenotomy and tenodesis are generally safe but can have complications. Tenotomy may lead to cosmetic changes in the arm, cramping, or reduced strength. Tenodesis can cause pain, infection, stiffness, and in rare cases, fractures or nerve injuries. ^{1 2 3 4 5}

How does the treatment of LHB Tenodesis and Tenotomy differ from other treatments for shoulder injuries?

LHB Tenodesis and Tenotomy are unique surgical treatments for shoulder injuries involving the long head of the biceps tendon, offering options to either cut the tendon (tenotomy) or reattach it to the bone (tenodesis). These procedures are particularly effective for managing pain and instability in the shoulder, with tenodesis helping to prevent muscle deformity and cramping during activity. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment LHB Tenodesis and Tenotomy for shoulder injury?

Research shows that both biceps tenodesis and tenotomy are effective surgical options for treating long head of the biceps tendon issues, providing good clinical outcomes and pain relief. Tenotomy may offer earlier pain relief compared to tenodesis, but both treatments are reliable for managing shoulder pain related to biceps tendon problems. ^{6 7 10 11 12}

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

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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

Biceps tenodesis versus tenotomy: a systematic review and meta-analysis of level I randomized controlled trials. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Prospective study of three surgical procedures for long head biceps tendinopathy associated with rotator cuff tears. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Biceps tenotomy has earlier pain relief compared to biceps tenodesis: a randomized prospective study. [2020]

4. United States 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. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Onlay Articular Margin Biceps Tenodesis for Long Head of the Biceps Tendon Pathology. [2020]

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

Complications of Proximal Biceps Tenotomy and Tenodesis. [2022]

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

Biomechanical analysis of subpectoral biceps tenodesis: effect of screw malpositioning on proximal humeral strength. [2018]

8. United States 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. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Biceps tenodesis versus biceps tenotomy for biceps tendinitis without rotator cuff tears. [2020]

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

Open subpectoral biceps tenodesis: reliable treatment for all biceps tendon pathology. [2018]

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

Clinical and Biomechanical Evaluation of an All-Arthroscopic Suprapectoral Biceps Tenodesis. [2020]

12. United States 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. [2021]