Abstract
Introduction
Pathology of the long head of the biceps tendon (LHBT) is commonly treated with either tenotomy or tenodesis, which provide comparable clinical outcomes but have distinct disadvantages. A novel self-locking biceps tenodesis aims to combine the benefits of both techniques. Comparative evidence in patients without full-thickness rotator cuff tears is limited. This study aims to compare the clinical outcomes and complications of self-locking biceps tenodesis and biceps tenodesis with 360° suture anchor in patients without full-thickness rotator cuff tears.
Methods and analysis
This single-centre, double-blinded non-inferiority randomised controlled trial will include 98 patients aged≥40 years with symptomatic LHBT pathology in the absence of full-thickness rotator cuff tears. Participants will be recruited between January 2025 and January 2030 and randomly allocated to self-locking biceps tenodesis or biceps tenodesis with 360° suture anchor. The primary outcome is the Constant score at 1 year postoperatively, with a predefined non-inferiority margin of 10 points.
Ethics and dissemination
This study received approval from the French Committee of Person Protection North-West II (national registration number 2024-A02217-40). Furthermore, the trial is registered at ClinicalTrials.gov (NCT06772103). Results will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.
Trial registration number
Keywords: Orthopaedic & trauma surgery, Shoulder, Randomized Controlled Trial
STRENGTHS AND LIMITATIONS OF THIS STUDY.
Prospective, double-blinded randomised controlled trial design with blinded data analysis reduces the risk of bias and enables robust comparison between treatment strategies.
Inclusion of patients without full-thickness rotator cuff tears allows for a more isolated assessment of the effect of long head of the biceps tendon treatment.
Comprehensive outcome assessment combining patient-reported, clinician-assessed, cosmetic and imaging-based measures provides a detailed evaluation of clinical and structural outcomes.
Objective assessment of tendon migration using a radio-opaque marker on serial imaging offers a novel and quantifiable method to evaluate postoperative tendon behaviour.
Concomitant procedures performed during surgery may introduce heterogeneity in outcomes despite strict inclusion criteria.
Introduction
The long head of the biceps tendon (LHBT) is a well-established source of shoulder pain, with pathology ranging from tendinopathy to instability and superior labrum anterior–posterior (SLAP) lesions.1 There is currently no consensus on a gold standard for the treatment of LHBT pathology.2 When surgical treatment is indicated, biceps tenotomy and biceps tenodesis are the most commonly performed procedures.3 Tenotomy of LHBT involves surgical release of the tendon without reattachment, whereas tenodesis involves release followed by fixation of the tendon to the humerus. Meta-analyses have shown comparable improvements in patient-reported and functional outcomes for both techniques.4–6 The main difference between these two surgical treatment options lies in the more technical demand and longer operating time associated with tenodesis and the higher prevalence of a Popeye sign due to tenotomy.7 In addition to cosmetic deformity, tenotomy may also result in muscle cramping. Conversely, anchor-based tenodesis techniques may lead to persistent anterior shoulder pain at the fixation site.
A self-locking tenodesis, described in the literature as ‘T or Y-shaped’ tenotomy or ‘tomyedesis’, has been proposed to combine the advantages of both biceps tenotomy and tenodesis.8–10 This technique involves cutting the LHBT at its glenoid origin, including resection of the superior labrum between the 11 o’clock and 1 o’clock positions, thereby creating a bulky segment at the end of the tenotomy. The underlying concept is that remaining tendon segment becomes entrapped within the bicipital groove and may be encased in scar tissue at this point, providing intrinsic stabilisation without the need for formal tenodesis. Therefore, this technique potentially reduces the amount of Popeye deformities associated with the standard tenotomy while at the same time reducing surgery time and minimising the use of surgical materials such as anchors compared with tenodesis technique.
Pathology of the LHBT is most frequently observed in association with rotator cuff tears and is therefore commonly treated concomitantly with rotator cuff repair.1 Isolated LHBT lesions without associated rotator cuff tears are relatively uncommon.11 To date, randomised controlled trials comparing surgical treatments for the LHBT have predominantly included patients with concomitant rotator cuff tears. As a result, it remains difficult to isolate the specific clinical effect of LHBT treatment, as postoperative pain relief and functional improvement may be attributable to the rotator cuff repair rather than the LHBT procedure itself. Therefore, to accurately compare biceps treatment techniques, studies in patients without full-thickness rotator cuff tears are required. Furthermore, prospectively randomised studies comparing the novel self-locking biceps tenodesis to more conventional tenodesis using suture anchors are lacking.
Therefore, the aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and biceps tenodesis with 360° suture anchor for the treatment of pathology of the LHBT or SLAP during shoulder arthroscopy in patients without full-thickness arthroscopic rotator cuff tears. A biceps tenodesis with 360° suture anchor was selected as the reference procedure because it is a well-validated and reproducible arthroscopic method that enables circumferential fixation of the capture while minimising tendon damage. In addition, it represents an arthroscopic supra-pectoral technique just like the self-locking tenodesis, with a comparable attachment site and surgical risk profile. Furthermore, both techniques rely on soft tissue healing and scar formation for definitive tendon stabilisation, with the primary difference being method of initial fixation of the tendon stump. As such, the biceps tenodesis with 360° suture anchor serves as a reliable and rigorous standard against which the self-locking tenodesis can be compared.
Objectives
Primary
To compare patient-reported shoulder function at 1 year after surgery between self-locking biceps tenodesis and 360° double lasso-loop biceps tenodesis in patients undergoing arthroscopic treatment for LHBT or SLAP pathology without full-thickness rotator cuff tears. The primary hypothesis is that patient-reported shoulder function at 1-year follow-up will not differ between the two tenodesis techniques.
Secondary
To compare clinical and imaging-based outcomes between both surgical techniques, including clinician-assessed shoulder function, range of motion, pain on examination, cosmetic appearance, postoperative tendon migration on imaging using a radio-opaque suture as a tag and perioperative parameters. In addition, complication rates related to LHBT treatment will be evaluated.
Methods and analysis
Study design and setting
This is a single-centre, double-blinded non-inferiority randomised controlled trial with blinded data analysis. Patients with symptomatic LHBT pathology requiring surgical treatment in the absence of rotator cuff tears will be randomly allocated in a 1:1 ratio to either the self-locking tenodesis group or the biceps tenodesis with 360° suture anchor group. Participants will be recruited at Clinique Générale d’Annecy (France), a mixed secondary and tertiary referral centre for shoulder pathology, with enrolment taking place from January 2025 to January 2030. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 recommendations for the reporting of interventional trial protocols.12
Eligibility criteria
To allow a more isolated assessment of the effect of LHBT treatment, the study focuses on patients with symptomatic LHBT pathology or SLAP lesions without full-thickness rotator cuff tears, partial-thickness are permitted. The study is limited to patients aged 40 years or older because surgical treatment of LHBT pathology in patients younger than 40 years is not routinely performed at our institution.
Inclusion criteria
Participants aged 40 years of age or older.
Pathology of the LHBT or SLAP-type lesion based on clinical symptoms.
Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI.
Exclusion criteria
Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI.
Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using anteroposterior radiography of the affected shoulder.
Previous surgery on the affected shoulder.
Patients presenting with motor paralysis of the shoulder.
Preoperative presence of the Popeye sign or documented LHBT rupture.
Dementia or inability to complete questionnaires and assessments in French or English.
Pregnant or breastfeeding patient, protected adult patient and patient not covered by social security.
Interventions
All patients undergoing LHBT treatment in this study will be operated on by specialised, fellowship-trained shoulder surgeons with a minimum of 5 years shoulder-specific experience, each of whom has performed the described procedures in over 100 cases.
Arthroscopic self-locking LHBT tenodesis
Operative management of the LHBT in patients allocated to this group will consist of the following procedure: the LHBT, together with the superior labrum between the 11 o’clock and 1 o’clock positions, is peeled off from the glenoid creating a bulky segment in a T-shaped or Y-shaped configuration (figure 1C). A radio-opaque 3–0 stainless steel suture (Ethicon, Somerville, New Jersey, USA) will be secured to the proximal portion of the LHBT at the level of the bicipital groove to facilitate postoperative tracking using radiographic imaging (figure 2). As the marker is attached before tenotomy, a small degree of distalisation of the marker is expected. However, this is performed in a standardised manner in both treatment groups.
Figure 1. Schematic overview of the surgical interventions: (A) normal anatomy, (B) biceps tenodesis with 360° suture anchor tenodesis technique and (C) self-locking tenodesis technique.
Figure 2. Intraoperative image of radio-opaque suture placed in the long head of the biceps tendon.
Arthroscopic biceps tenodesis with 360° suture anchor
Operative management of the LHBT in patients allocated to this group will consist of arthroscopic circumferential double loop suture with a transtendinous passage before cutting the tendon.10 This configuration allows for fixation of the tendon within the bicipital groove using an anchor (figure 1B). A radio-opaque 3–0 stainless steel suture (Ethicon) will be secured to the proximal portion of the LHBT at the level of the bicipital groove to facilitate postoperative tracking using radiographic imaging (figure 2). As the marker is attached before tenotomy, a small degree of distalisation of the marker is expected. However, this is performed in a standardised manner in both treatment groups.
Concomitant procedures
Concomitant procedures may be performed when indicated and include Bankart repair, distal clavicle resection, subacromial decompression and repair of partial-thickness rotator cuff tears. These procedures are not considered exclusion criteria. All concomitant procedures will be recorded and reported and their potential influence on outcomes will be considered in the final analysis.
Rehabilitation
Postoperative rehabilitation is independent of the allocated group. A shoulder sling with an abduction cushion will be used during the first week after surgery for pain management, though without restriction. Initiating exercises under the supervision of a specialised shoulder physiotherapist after a few days is encouraged. After this initial period, active shoulder movements will be progressively introduced. Patients will be advised to avoid heavy lifting and intense physical activities for the first 3 months following the surgery.
Outcomes (primary and secondary)
The primary outcome of this study is the Constant score (CS) assessed at 1 year postoperatively. The CS is a 100-point composite measure comprising patient-reported domains for pain (15 points) and activities of daily living (20 points), accounting for 35 points; and clinician-assessed domains for shoulder strength (25 points) and range of motion (40 points), accounting for 65 points. As CS values are influenced by age and sex, all scores will be adjusted using the normalisation method described by Katolik et al.13
Secondary outcomes will include the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Value (SSV) and the the long head of the biceps (LHB) score.14 Additional secondary measures comprise patient-assessed and clinician-assessed cosmetic appearance, pain intensity assessed using a visual analogue scale at rest, during activity and specifically over the bicipital groove, migration of the LHBT on plain radiographs using the radio-opaque marker, as well as postoperative imaging findings on MRI or ultrasound.
Pre-operative assessment
At the pre-operative baseline visit following enrolment, patient demographics and several outcome measures will be recorded, including the CS, LHB score, cosmetic baseline appearance of the upper arm, and findings from MRI or ultrasound. History of previous contralateral shoulder surgery will also be recorded, as this may influence strength-based outcome measures such as the LHB score, and will be considered when interpreting the results. Muscle strength required for calculation of the CS and LHB scores will be measured using a dynamometer. Baseline cosmetic appearance will be documented using standardised digital photographs of the flexed upper arm obtained from anterior and bilateral lateral views (figure 3). In addition, participants will complete questionnaires capturing demographic information, pain characteristics (pain at rest, during activity and over the bicipital groove) and patient-reported outcome measures, including the CS, ASES score, SSV and a dedicated cosmetic appearance questionnaire.
Figure 3. Standardised biceps photograph used for cosmetic assessment.
Post-operative assessment
Postoperative assessments will be performed at 6 weeks, 3 months, 6 months and 1 year after surgery. The schedule of data collection and outcome measures at each follow-up visit is outlined in table 1.
Table 1. Overview follow-up time points and outcome measures.
| Time point | PROMs | CROMs |
|---|---|---|
| Direct postoperatively | – |
|
| 6 weeks |
|
|
| 3 months |
|
|
| 6 months |
|
|
| 1 year |
|
|
ASES, American Shoulder and Elbow Surgeons; CROM, clinician-reported outcome measures; LHB, The long head of the biceps; PROM, patient-reported outcome measures; SSV, Simple Shoulder Value.
Post-operative assessment
Outcome assessments at all follow-up visits will be performed by dedicated research fellows who are blinded to treatment allocation. Assessors are instructed not to access the operative report, which is the only document containing information regarding the surgical technique performed. Treating surgeons may review patients as part of routine clinical care, but study outcomes included in the analysis are collected exclusively by the blinded assessors.
Postoperative imaging assessment
Postoperative imaging will be performed to assess the position of the LHBT over time. Serial, scale-calibrated radiographs will be obtained to monitor postoperative LHBT position. At each follow-up visit, standardised anteroposterior and Y-view radiographs will be obtained. If a radiograph is considered non-comparable due to substantial difference in positioning or projection, it will be excluded from the radiographic migration analysis. The distance between the radio-opaque marker attached to the LHBT and the apex of the humeral head will be measured on each radiograph. Changes in this distance across follow-up time points will be used to evaluate postoperative migration of the LHBT. In addition, MRI or ultrasound performed at 1 year postoperatively will be used for final assessment of LHBT location. MRI will be performed in all patients, ultrasound will only be used in patients unable or unwilling to undergo MRI, for example, due to claustrophobia.
Enrolment
Patients who meet the predefined inclusion and exclusion criteria will be considered eligible for participation. Eligible patients will receive a comprehensive explanation of the study aims and design, after which written informed consent will be obtained from those who agree to participate. Participation will be voluntary, and patients will be informed that they may withdraw at any time without consequences for their care. Following consent by a signed form, participants will be randomised by the researcher using an online randomisation platform (Study Randomizer; Phase Locked Software, Wageningen, The Netherlands; 2021). Randomisation will be performed with a 1:1 allocation ratio using permuted blocks of four patients and will not be stratified for baseline characteristics. Intraoperatively, if findings reveal a full-thickness rotator cuff tear which does not meet the predefined inclusion criteria, the patient will be excluded from further participation in the study. Participants will remain blinded to treatment allocation, with group assignment disclosed only after completion of the final 1-year postoperative assessment. Figure 4 provides an overview of the study flowchart.
Figure 4. Study flow chart.
Sample size
The trial is designed to test the non-inferiority of self-locking LHBT tenodesis compared with biceps tenodesis with 360° suture anchor in patients aged 40 years or older with LHBT pathology in the absence of full-thickness rotator cuff tears, with functional outcome assessed at 1 year postoperatively. As condition-specific data on the minimal clinically important difference (MCID) for the CS at 1-year follow-up in isolated LHBT pathology are unavailable, MCID estimates reported by Kukkonen et al in the context of rotator cuff surgery were used as a surrogate reference.15 On this basis, a non-inferiority margin of 10 CS points and an assumed SD of 16 points were applied. With a one-sided two-sample t-test, 80% statistical power and an alpha level of 0.025, 41 patients per group were required. To account for an expected dropout rate of approximately 20%, the planned total sample size was increased to 98 participants.
Data management
All study data will be stored in a secure, password-protected electronic database. Participant information will be pseudonymised using unique identification codes, with the corresponding key maintained separately. Regular backups will be performed to ensure data security and integrity.
Statistical analysis plan
Statistical analyses will be conducted using R software (R Foundation for Statistical Computing, Vienna, Austria). All analyses will be performed according to the per-protocol principle. The primary objective is to evaluate whether self-locking LHBT tenodesis is non-inferior to biceps tenodesis with 360° suture anchor with respect to the CS at 1-year follow-up. Initial between-group comparisons of the CS will be performed using an independent-samples t-test. Owing to the non-inferiority design, statistical significance for the primary outcome will be defined as a one-sided p value <0.025.
Changes in outcomes over time will be analysed using longitudinal regression techniques, including linear mixed-effects models or generalised estimating equations, to compare postoperative recovery patterns between treatment groups. In these models, the CS will be specified as the dependent variable, with treatment group and follow-up time entered as fixed effects; relevant covariates such as age will be incorporated to account for potential baseline differences. Comparable models will be built for secondary outcomes, including pain scores and cosmetic assessments. For secondary analyses, two-sided p values <0.05 will be considered statistically significant. Associations between continuous patient-reported and clinician-assessed outcome measures will be examined using appropriate correlation coefficients.
Discussion
The aim of this randomised controlled trial is to compare the self-locking tenodesis to biceps tenodesis with 360° suture anchor in patients with absence of full-thickness rotator cuff tears. LHBT pathology is most commonly encountered in association with rotator cuff tears; consequently, there are relatively few studies in the literature comparing tenotomy and tenodesis in patients without concomitant rotator cuff repair.11
This study will have several notable strengths. First, the selection of the patient population allows for a more direct evaluation of the clinical effect of LHBT treatment itself, as only patients without full-thickness rotator cuff pathology are included. Moreover, by focusing on this specific population, the study addresses an important gap in the current literature, as evidence regarding LHBT treatment in the absence of full-thickness rotator cuff tears remains limited. Second, the randomised controlled design represents a key methodological strength. Previous studies comparing the self-locking tenodesis technique with other LHBT treatment strategies have been non-randomised.9 10 Such study designs are inherently prone to selection bias, as surgeons often preferentially select conventional tenodesis in younger male patients to reduce the risk of Popeye deformity and associated dissatisfaction with cosmetic appearance.16 Finally, a major strength of this study is the detailed and systematic assessment of postoperative outcomes following surgery, including cosmetic appearance and LHBT migration. Tendon migration will be monitored using a radio-opaque marker placed intraoperatively and evaluated on serial follow-up radiographs, with additional confirmation by MRI or ultrasound at 1 year. This approach enables objective assessment of postoperative tendon migration. In addition, a broad range of outcome measures is incorporated, including validated patient-reported outcome instruments, pain assessment and cosmetic evaluation from both the patient’s and clinician’s perspective, allowing for a thorough assessment of treatment effects.
Several limitations of this study should be considered. The inability to blind the operating surgeons, inherent to the comparison of two distinct surgical techniques, may introduce performance bias; this risk is mitigated through patient blinding, blinded outcome assessment by dedicated research fellows and blinded data analysis. In addition, the single-centre design may limit external validity, although the use of highly standardised surgical and rehabilitation protocols may support reproducibility in other clinical settings. The strict inclusion criteria may further limit the applicability of the findings to patients with combined shoulder pathology such as rotator cuff tears. Although full-thickness rotator cuff tears are excluded from the analysis, other concomitant procedures may still be performed intraoperatively, potentially introducing heterogeneity. However, isolated LHBT pathology requiring surgical treatment is relatively uncommon in clinical practice, and allowing concomitant procedures could improve the generalisability of the study findings.7 The potential influence of concomitant procedures on treatment effects will be considered for the final analysis. Finally, while a 1-year follow-up period is commonly used in orthopaedic trials, it may be insufficient to detect late-onset complications or long-term functional changes.
This study addresses an important clinical question regarding the optimal surgical management of LHBT pathology by directly comparing self-locking tenodesis to biceps tenodesis with 360° suture anchor in patients without full-thickness rotator cuff tears. By integrating clinical, cosmetic and objective imaging outcomes, the results may help clarify which technique offers the most favourable balance between effectiveness and complications. In addition, the self-locking tenodesis may offer potential advantages in terms of reduced operative time and cost-efficiency. The findings of this trial are expected to contribute to more evidence-based selection of surgical treatment for LHBT pathology.
Ethics and dissemination
This study received approval from the French Committee of Person Protection North-West II (national registration number 2024-A02217-40). Participants will not receive financial compensation for their involvement and have the right to withdraw from the study at any time. The findings of this study will be submitted for publication in a peer-reviewed journal, and the results will also be presented at international scientific conferences.
Registration details
This trial is registered on ClinicalTrials.gov (identifier: NCT06772103). More detailed information is presented in table 2.
Table 2. Trial registration data.
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | ClinicalTrials.gov: NCT06772103 |
| Date of registration in primary registry | 8 January 2025 |
| Secondary identifying numbers | 2024-43-CGA |
| Source(s) of monetary or material support | Vivalto Santé |
| Primary sponsor | Vivalto Santé |
| Secondary sponsor(s) | N.a. |
| Contact for public queries | DB |
| Contact for scientific queries | DB |
| Public title | Biceps tenodesis with 360° suture anchor versus self-locking tenodesis in the absence of full-thickness rotator cuff tears: a randomised controlled trial (BLAST 2) |
| Scientific title | Biceps tenodesis with 360° suture anchor versus self-locking tenodesis in the absence of full-thickness rotator cuff tears: a randomised controlled trial |
| Countries of recruitment | France |
| Health condition(s) or problem(s) studied | Long head biceps tendon pathology |
| Intervention(s) | Biceps tenodesis with 360° suture anchor |
| Self-locking biceps tenodesis | |
| Key inclusion and exclusion criteria | Inclusion criteria
|
Exclusion:
|
|
| Study type | Interventional |
| Allocation: randomised intervention model | |
| Date of first enrolment | 22 January 2025 |
| Target sample size | 98 |
| Recruitment status | Recruiting |
| Primary outcome(s) | Constant score 1 year after surgery |
| Key secondary outcomes | LHB score, ASES score, location of biceps tendon and presence of Popeye sign 1 year after surgery |
AP, anteroposterior; ASES, American Shoulder and Elbow Surgeons; LHB, The long head of the biceps ; LHBT, long head of the biceps tendon; SLAP, superior labrum anterior–posterior.
Acknowledgements
The authors would like to thank A Shirinskaya for creating the medical illustrations and the design of figure 1.
Footnotes
Funding: This work is supported by Vivalto Santé (Grant number: 2024-43-CGA).
Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2026-120296)
Patient consent for publication: Not applicable.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Presented at: This work has not been previously presented at any conference, and no abstracts related to this study have been published.
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