Biceps Tendon DisorderNCT06815796
Loop vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon
A study testing Arthroscopic Loop tenodesis of long head of biceps. and Anchor Tenodesis of Long head of biceps tendon in people with Biceps Tendon Disorder and Shoulder Arthroscopic Surgery, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
The goal of this clinical trial is to learn if loop tenodesis is as effective as suture anchor tenodesis for treating long head of biceps (LHB) pathology. It will also assess the safety and outcomes of both techniques. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Biceps Tendon Disorder, Shoulder Arthroscopic Surgery
- What is being tested?
- Arthroscopic Loop tenodesis of long head of biceps. and Anchor Tenodesis of Long head of biceps tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients requiring a tenodesis of the long head of the biceps tendon during the study period, using either anchor tenodesis or loop tenodesis.
- Patients must be at least 18 years old.
- Patients must have the capacity to give informed consent.
Who cannot join
- Patients with insufficient documentation.
- Patients under the age of 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Loop vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon. A Prospective, Randomized, Double-blinded Study
The goal of this clinical trial is to learn if loop tenodesis is as effective as suture anchor tenodesis for treating long head of biceps (LHB) pathology. It will also assess the safety and outcomes of both techniques. The main questions it aims to answer are:
How effective is loop tenodesis compared to suture anchor tenodesis in preventing shoulder deformities and maintaining biomechanical strength? What complications or failures occur with each technique? Researchers will compare suture anchor tenodesis using the Arthrex FiberTak system with loop tenodesis (an implant-free technique).
Read more
Participants will:
Undergo surgery with either suture anchor tenodesis or loop tenodesis, assigned randomly.
Be informed about the procedure and sign a consent form prior to surgery. Have their clinical outcomes evaluated and compared before and after their treatment.
Read the detailed description
A pathology of the long head of the biceps tendon (LHB) is often the cause of shoulder pain. There are numerous ways to treat an LHB pathology. Arthroscopic biceps tenotomy is a simple method to address this condition. However, it often results in a cosmetic "Popeye deformity" and reduced strength during abduction. For this reason, and due to advancements in anchor systems, arthroscopic biceps tenodesis using an anchor in the bicipital groove is becoming increasingly popular. The advantage of this method is that it prevents potential muscle deformity and provides stable fixation in the bicipital groove. Possible disadvantages include potential failure and the cost of the anchors used.
A newer method with good biomechanical and clinical outcomes is the so-called arthroscopic loop tenodesis. In this technique, the LHB is proximally detached at its insertion and shuttled extracapsularly using a clamp. The end of the tendon is then folded and sutured into a so-called "loop." The tendon is released, and after spontaneous retraction, it forms a so-called autotenodesis in the bicipital groove. This technique has the advantage of providing implant-free fixation while also demonstrating good biomechanical outcomes.
The goal of this study is to investigate and compare the clinical success rate after arthroscopic treatment of the LHB using either a suture anchor tenodesis (Arthrex FiberTak) or the so-called loop tenodesis (implant-free fixation). The study is being conducted in the Orthopedics Department of the Ordensklinikum Linz - Barmherzige Schwestern, Austria.
All patients requiring arthroscopic biceps tenodesis at the Orthopedics Department of the Ordensklinikum Linz will be treated using either suture anchor tenodesis or loop tenodesis. Allocation to the surgical technique will be determined by block randomization (block length = 9) immediately after the decision to include the patient in the study. Block randomization using a random number generator is chosen to ensure that the group sizes are approximately equal.
Before surgery, patients will be informed about the study process and the possibility of participation during a personal consultation. They will also receive a patient information and consent form in which their agreement to participate is documented in writing. Patients will receive a copy of the signed consent form, while the original remains with the investigator.
The data collected in this study will be analyzed individually and compared with existing data in the literature. The results will then be taken into account when considering various treatment concepts, potentially leading to adjustments or optimizations to benefit the patients.
- Being tested
- Arthroscopic Loop tenodesis of long head of biceps., Anchor Tenodesis of Long head of biceps tendon
- Keywords
- Biceps Tendon Pathology, Arthroscopic Tenodesis, Loop Tenodesis, Suture Anchor Tenodesis, Clinical outcomes, Return to sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Loop tenodesis of long head of biceps.Procedure or surgery
Loop tenodesis of the long head of biceps tendon.
Anchor Tenodesis of Long head of biceps tendonProcedure or surgery
Anchor Tenodesis of Long head of biceps tendon
| Study group | Role | What they receive |
|---|---|---|
| Loop tenodesis of Long head of biceps tendon | Experimental | Long head of biceps tenodesis using loop technique Receives: Procedure: Arthroscopic Loop tenodesis of long head of biceps. |
| Anchor tenodesis of Long head of biceps tendon | Active comparator | Long head of biceps tenodesis using anchor technique Receives: Procedure: Anchor Tenodesis of Long head of biceps tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score
score ranges from 0 to 100 points, representing worst and best shoulder function
Measured: up to 24 months
American Shoulder and Elbow Surgeons score (ASES)
ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function
Measured: up to 24 months
Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire
scored 0 (no disability) to 100
Measured: up to 24 months
Secondary outcomes (10)
Cosmetic Outcome
Incidence of "Popeye deformity" post-surgery
Measured: up to 24 months
Strength
Supination of the forearm in 90 degree elbow flexion in kilogram
Measured: up to 24 months
Complications
Rate of complications (anchor failure, Pop-eye deformity, infections, pain etc.)
Measured: up to 24 months
Pain (pre-/postOP)
assessed using a Visual Analog Scale (VAS). two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: up to 24 months
Sport activities
assessed using a questionnaire
Measured: up to 24 months
Level of sport
assessed using a questionnaire (amateur (no salary), professional (salary)
Measured: up to 24 months
Sport duration
assessed using a questionnaire (1x/2x/3x/4x/>4x per week; 0-15 min, 16-30 min, 31-60 min, 61-120 min, > 120 min per day)
Measured: up to 24 months
Return to sport
assessed using a questionnaire (months)
Measured: up to 24 months
Pain during sport
assessed using a questionnaire with virtual analag scale (pre- and postOP; VAS 0-10, 0= no pain, 10= maximal pain)
Measured: up to 24 months
Fear during sport
assessed using a questionnaire with virtual analog scale (pre- and postOP; VAS 0-10, 0= no fear, 10= maximal fear)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jan 2023
- Primary completion31 Aug 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps Tendon DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized allocation to 2 groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815796
- Sponsor's protocol ID
- EK 1249/2022
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared upon request, due to government privacy policy routine uploading of specific data can not be done.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon. A Prospective, Randomized, Double-blinded Study
- ClinicalTrials.gov ID
- NCT06815796
- Acronym / sponsor ID
- EK 1249/2022
- Keywords
- Biceps Tendon Pathology, Arthroscopic Tenodesis, Loop Tenodesis, Suture Anchor Tenodesis, Clinical outcomes, Return to sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Feb 2025 (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 goal of this clinical trial is to learn if loop tenodesis is as effective as suture anchor tenodesis for treating long head of biceps (LHB) pathology. It will also assess the safety and outcomes of both techniques. The main questions it aims to answer are:
How effective is loop tenodesis compared to suture anchor tenodesis in preventing shoulder deformities and maintaining biomechanical strength? What complications or failures occur with each technique? Researchers will compare suture anchor tenodesis using the Arthrex FiberTak system with loop tenodesis (an implant-free technique).
Participants will:
Undergo surgery with either suture anchor tenodesis or loop tenodesis, assigned randomly.
Be informed about the procedure and sign a consent form prior to surgery. Have their clinical outcomes evaluated and compared before and after their treatment.
Detailed description
A pathology of the long head of the biceps tendon (LHB) is often the cause of shoulder pain. There are numerous ways to treat an LHB pathology. Arthroscopic biceps tenotomy is a simple method to address this condition. However, it often results in a cosmetic "Popeye deformity" and reduced strength during abduction. For this reason, and due to advancements in anchor systems, arthroscopic biceps tenodesis using an anchor in the bicipital groove is becoming increasingly popular. The advantage of this method is that it prevents potential muscle deformity and provides stable fixation in the bicipital groove. Possible disadvantages include potential failure and the cost of the anchors used.
A newer method with good biomechanical and clinical outcomes is the so-called arthroscopic loop tenodesis. In this technique, the LHB is proximally detached at its insertion and shuttled extracapsularly using a clamp. The end of the tendon is then folded and sutured into a so-called "loop." The tendon is released, and after spontaneous retraction, it forms a so-called autotenodesis in the bicipital groove. This technique has the advantage of providing implant-free fixation while also demonstrating good biomechanical outcomes.
The goal of this study is to investigate and compare the clinical success rate after arthroscopic treatment of the LHB using either a suture anchor tenodesis (Arthrex FiberTak) or the so-called loop tenodesis (implant-free fixation). The study is being conducted in the Orthopedics Department of the Ordensklinikum Linz - Barmherzige Schwestern, Austria.
All patients requiring arthroscopic biceps tenodesis at the Orthopedics Department of the Ordensklinikum Linz will be treated using either suture anchor tenodesis or loop tenodesis. Allocation to the surgical technique will be determined by block randomization (block length = 9) immediately after the decision to include the patient in the study. Block randomization using a random number generator is chosen to ensure that the group sizes are approximately equal.
Before surgery, patients will be informed about the study process and the possibility of participation during a personal consultation. They will also receive a patient information and consent form in which their agreement to participate is documented in writing. Patients will receive a copy of the signed consent form, while the original remains with the investigator.
The data collected in this study will be analyzed individually and compared with existing data in the literature. The results will then be taken into account when considering various treatment concepts, potentially leading to adjustments or optimizations to benefit the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized allocation to 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Loop tenodesis of Long head of biceps tendon | Experimental | Procedure: Arthroscopic Loop tenodesis of long head of biceps.Long head of biceps tenodesis using loop technique |
| Anchor tenodesis of Long head of biceps tendon | Active comparator | Procedure: Anchor Tenodesis of Long head of biceps tendonLong head of biceps tenodesis using anchor technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients requiring a tenodesis of the long head of the biceps tendon during the study period, using either anchor tenodesis or loop tenodesis.
- Patients must be at least 18 years old.
- Patients must have the capacity to give informed consent.
Key exclusion criteria (2 listed)
- Patients with insufficient documentation.
- Patients under the age of 18.
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 |
|---|---|---|
| Arthroscopic Loop tenodesis of long head of biceps.Loop tenodesis of the long head of biceps tendon. | Procedure or surgery | Loop tenodesis of Long head of biceps tendon |
| Anchor Tenodesis of Long head of biceps tendonAnchor Tenodesis of Long head of biceps tendon | Procedure or surgery | Anchor tenodesis of Long head of biceps tendon |
Primary outcome
Constant-Murley Score
Time frame: up to 24 months
score ranges from 0 to 100 points, representing worst and best shoulder function
American Shoulder and Elbow Surgeons score (ASES)
Time frame: up to 24 months
ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function
Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire
Time frame: up to 24 months
scored 0 (no disability) to 100
10 secondary outcomes
Cosmetic Outcome
Time frame: up to 24 months
Strength
Time frame: up to 24 months
Complications
Time frame: up to 24 months
Pain (pre-/postOP)
Time frame: up to 24 months
Sport activities
Time frame: up to 24 months
Level of sport
Time frame: up to 24 months
Sport duration
Time frame: up to 24 months
Return to sport
Time frame: up to 24 months
Pain during sport
Time frame: up to 24 months
Fear during sport
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. IPD can be shared upon request, due to government privacy policy routine uploading of specific data can not be done.
Related trials for Biceps Tendon Disorder
Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
Rotator Cuff Tear, Pain Management
RecruitingObservational study
Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon
Biceps Tendon Disorder
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Not yet recruiting
Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
Rotator Cuff Tear Surgical Repair
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Loop tenodesis of long head of biceps. and Anchor Tenodesis of Long head of biceps tendon in people with Biceps Tendon Disorder and Shoulder Arthroscopic Surgery, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 2026. 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 Austria. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (time frame: up to 24 months). 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 3 Jun 2026.