ESTABLE: A Randomized Control Trial of Shoulder Instability Using the Latarjet Procedure With Suture Tape Cerclage Versus Screw Fixation
Phase: NA
Conditions: Shoulder Instability, Shoulder, Latarjet, Anterior Shoulder Instability, Anterior Shoulder Dislocation
Sponsor: Juan Ameztoy

STUDY TITLE 
ESTABLE: Shoulder Stability Study Using the Latarjet Procedure with Suture 
Tape Cerclage versus Screw Fixation 
Principal Investigator: 
Juan Ameztoy Gallego 
juan.ameztoy@salud.madrid.org 
Department of Orthopaedic Surgery and Traumatology 
Hospital Universitario La Paz 
Version: 2 – September 9, 2025 
 
Table of Contents 
1. Abstract 
2. Background and Rationale 
3. Hypothesis and Objectives 
4. Study Design 
5. Study Population 
6. Study Variables 
7. Data Source 
8. Statistical Analysis Plan 
9. Ethical Considerations 
9.1. General and Specific Investigator Responsibilities 
9.2. Benefit–Risk Assessment 
9.3. Informed Consent (if applicable) 
9.4. Data Security and Confidentiality Measures 
10. Data Management 
10.1. Compliance with European/National Legislation 
10.2. Privacy Protection 
10.3. Data Access and Use Limitations (if applicable) 
11. Biological Sample Management (if applicable) 
11.1. Sample Collection and Storage 
11.2. Biobank Storage (if applicable) 
11.3. Sample Transfer (if applicable) 
11.4. Information in the Participant Information Sheet Regarding Future Studies 
11.5. Genetic Analyses 
12. Detection, Collection, and Reporting of Adverse Drug Reactions (ADR) 
13. Timeline 

14. Publication and Transparency 
14.1. Registration 
14.2. Publication of Results 
14.3. Data Transparency Policy 
14.4. Communication of Results to Patients and Society 
15. Funding 
16. Conflict of Interest 
 
1. Abstract 
General Objective 
To compare the clinical and radiological outcomes of coracoid bone graft fixation in the 
Latarjet procedure using high-strength suture tape versus metallic screw fixation in 
patients with anterior shoulder instability, through a randomized non-inferiority clinical 
trial. 
Study Design and Setting 
This is a prospective, single-center, randomized clinical trial with assessor blinding, 
conducted at Hospital Universitario La Paz. 
Randomization will be performed using permuted blocks, stratified by age (<30 years / 
≥30 years), with a 1:1 allocation ratio. 
The experimental group will receive coracoid graft fixation using high-strength suture 
tape (FiberTape Cerclage). 
The control group will receive standard fixation using two metallic screws. 
The surgical technique, approach, and rehabilitation protocol will be identical in both 
groups, standardized and performed by the same surgical team. 
Inclusion Criteria 
• 
Patients aged 18 to 50 years 
• 
Diagnosis of anterior shoulder instability 
• 
Indication for Latarjet surgery 
Exclusion Criteria 
• 
Surgical contraindication 
• 
Concomitant lesions: rotator cuff pathology or biceps tendon pathology 

• 
Previous surgery on the affected shoulder 
• 
Systemic or neurovascular conditions that may influence outcomes 
The calculated sample size is 80 patients, considering a 10% loss to follow-up to detect 
clinically relevant differences in the functional scale used as the primary endpoint. 
 
2. Background and Rationale 
Anterior shoulder instability is a common clinical condition, particularly in young 
patients, athletes, and individuals with high functional demands. The open Latarjet 
procedure is a widely used surgical technique for treating anterior shoulder instability, 
especially in patients with significant glenoid bone loss, with good functional outcomes. 
Traditionally, coracoid graft fixation has been performed using two cortical screws, 
providing rigid fixation and compression at the bone interface. However, in clinical 
practice, complications related to osteosynthesis hardware have been reported, prompting 
interest in more biocompatible and versatile alternatives. 
Recent studies have documented a significant rate of screw-related complications, 
including hardware irritation and persistent anterior shoulder pain [1,2], screw loosening 
particularly when graft union is incomplete [3], stress-induced coracoid graft fractures 
around screw sites [4], and the need for revision surgery for hardware removal, with 
some series reporting rates up to 16% [1,2]. 
These complications may compromise clinical outcomes, delay rehabilitation, increase 
healthcare costs, and contribute to patient morbidity. 
In response to these limitations, Hachem et al. [5] proposed the use of high-strength 
suture tape (FiberTape, Arthrex) as a fixation alternative without rigid metallic implants. 
This technique involves passing two interconnected tapes through transverse bone tunnels 
and tying them under controlled tension, achieving compression without metal hardware. 
This approach has been validated at three levels: 
1. Surgical technique: Hachem et al. [5] described the technique in detail and 
demonstrated that it maintains axial compression and rotational stability of the 
graft without screws, while facilitating future arthroscopy or revision procedures 
by avoiding metallic implants. 
2. Clinical validation: In a prospective series of more than 30 patients treated with 
FiberTape, graft union rates exceeded 90%, with no graft fractures or need for 
hardware removal. Clinical outcomes measured using the WOSI and other 
functional scales were equivalent or superior to those reported with traditional 
screws [5]. 

3. Biomechanical validation: In a biomechanical study by Hachem et al. [6], 
directly comparing FiberTape with bicortical screws, suture tape fixation 
demonstrated comparable ultimate load to failure, lower stiffness (potentially 
reducing stress concentration on the graft), and equivalent graft displacement 
under simulated cyclic loading conditions. 
Given the increasing number of complications attributable to screw fixation in the 
Latarjet procedure, high-strength suture tape fixation represents a biomechanically sound, 
clinically safe, and potentially superior alternative in terms of biological tolerance and 
long-term complication profile. 
 
3. Hypothesis and Objectives 
Primary Hypothesis 
Coracoid graft fixation in the Latarjet procedure using high-strength suture tape 
(FiberTape Cerclage) is non-inferior to traditional metallic screw fixation in terms of 
functional recovery at 12 months and may be associated with a lower rate of fixation-
related complications. 
Primary Objective 
To compare functional efficacy between high-strength suture tape fixation and metallic 
screw fixation in the Latarjet procedure, assessed using the total score of the Western 
Ontario Shoulder Instability Index (WOSI) at 12 months, in a randomized non-inferiority 
clinical trial. 
Secondary Objectives 
1. To evaluate coracoid graft union rate using computed tomography (CT) at 3 and 
12 months postoperatively in both groups. 
2. To analyze graft position relative to the glenoid and its angulation in axial and 
sagittal planes using CT. 
3. To compare postoperative complication rates between groups, including graft 
fracture, significant bone resorption, graft or fixation malposition, and need for 
revision surgery. 
 

4. Study Design 
This is a prospective, single-center, randomized clinical trial comparing two methods of 
coracoid graft fixation in the Latarjet procedure: conventional metallic screw fixation and 
high-strength suture tape fixation (FiberTape Cerclage). 
Participants will be assigned in a 1:1 ratio using permuted block randomization, stratified 
by age group (<30 years and ≥30 years) to ensure sample homogeneity. 
Surgeons performing the procedure will be aware of the fixation technique, as 
intraoperative blinding is not feasible. However, clinical and radiological outcome 
assessors will be blinded to group allocation to minimize assessment bias. 
Both groups will follow a standardized surgical protocol and identical postoperative 
rehabilitation regimen. A minimum follow-up of 12 months will be conducted for all 
patients. 
The study will be conducted at a single hospital center, Hospital Universitario La Paz, 
with experience in shoulder surgery, and will include consecutive patient recruitment 
until the calculated sample size is reached. 
 
5. Study Population 
All patients diagnosed with anterior shoulder instability who freely agree to participate 
will be consecutively included until the estimated sample size is achieved. 
Inclusion Criteria 
Participants must meet all of the following criteria: 
1. Age between 18 and 50 years 
2. Diagnosis of anterior shoulder instability 
3. Indication for surgical treatment with the Latarjet procedure 
4. Provision of written informed consent 
Exclusion Criteria 
Participants will be excluded if any of the following are present: 
1. Multidirectional or posterior shoulder instability 
2. Previous surgery on the affected shoulder 

3. Concomitant associated pathology: rotator cuff tear, glenohumeral osteoarthritis, 
long head of the biceps lesions, etc. 
4. Upper limb conditions unrelated to the current episode that may influence study 
outcomes (fractures, motor paralysis due to systemic or neurovascular diseases, 
etc.) 
6. Study Variables 
The following variables will be collected: 
1. Demographic Variables 
Age, sex, affected side, limb dominance, type of instability, age at first dislocation 
episode, number of dislocation episodes, number of subluxation episodes, hyperlaxity, 
range of motion, sports activity, type of sport, occupational activity. 
2. Radiological Variables 
At study inclusion, computed tomography (CT) will be used to assess: 
• 
Glenoid bone loss 
• 
Humeral Hill-Sachs lesion 
• 
Glenoid track 
At 3 months and 12 months postoperatively, CT scans will evaluate: 
• 
Graft union 
• 
Alpha angle to determine graft position 
• 
Graft height 
• 
Degenerative changes 
• 
Complications 
3. Early and Late Postoperative Complications 
Complications related to surgery will be recorded and classified as early or late events. 
4. Clinical and Functional Assessment 
Clinical and functional outcomes will be evaluated at 3 months, 12 months, and, if 
applicable, 24 months after surgery. 
Objective data will be collected regarding: 
• 
Functional status 
• 
Range of motion 

• 
Muscle strength of the operated limb 
Return to work and return to sport will be assessed. 
Shoulder mobility will be measured using a goniometer. 
Clinical, functional, and quality-of-life outcomes will be assessed using validated scales 
routinely used in the Department of Orthopaedic Surgery at Hospital Universitario La 
Paz: 
a. WOSI (Western Ontario Shoulder Instability Index) – Appendix I 
b. Subjective Shoulder Value (SSV) – Appendix II 
c. ROWE Score – Appendix III 
d. Visual Analog Scale (VAS) for pain – Appendix IV 
 
7. Data Source 
Data collection will be performed using the patient’s electronic medical record within the 
HCIS system of Hospital Universitario La Paz. 
Data will be pseudonymized by assigning each participant a study reference number. 
Data will be stored in Microsoft Excel databases and secured on the servers of Hospital 
Universitario La Paz for subsequent analysis. 
Data will be retained for the duration of the study and for a maximum period of 10 years 
thereafter to comply with potential legal obligations arising from the study. 
 
8. Statistical Analysis Plan 
Data collected through clinical case report forms and patient consultations will be entered 
into databases for subsequent analysis. 
Sample Size Calculation 
The sample size was calculated to detect a minimal clinically important difference 
(MCID) of 210 points on the WOSI scale (10% of the total score), assuming a standard 
deviation of 450 points, a one-sided alpha error of 0.025, and a statistical power of 80% 
(beta = 0.2). 

This resulted in a required sample of 72 patients (36 per group). Considering a potential 
10% loss to follow-up, the final sample size was set at 80 patients (40 per group). 
Baseline Analysis 
Prior to the primary analysis, baseline characteristics of both groups will be described to 
assess homogeneity following randomization. 
• 
Continuous variables will be expressed as mean ± standard deviation or median 
and interquartile range if non-normally distributed. 
• 
Categorical variables will be expressed as absolute frequencies and percentages. 
Statistical Tests 
The following tests will be applied according to data type and distribution: 
• 
Kolmogorov–Smirnov test to assess normality 
• 
Independent Student’s t-test or Mann–Whitney U test for comparison of 
continuous variables between groups 
• 
Chi-square test or Fisher’s exact test for categorical variables 
Primary Analysis 
The primary analysis will compare total WOSI score at 12 months postoperatively 
between the two groups. 
The primary hypothesis is that high-strength suture tape fixation is non-inferior to 
metallic screw fixation. 
A non-inferiority analysis for independent means will be performed using a one-sided t-
test with a predefined non-inferiority margin of 210 WOSI points (10% of total score). 
Both intention-to-treat and per-protocol analyses will be conducted in accordance with 
recommendations for non-inferiority trials. 
A one-sided 95% confidence interval for the difference between groups will be 
calculated. 
Secondary Analyses 
• 
Pain (VAS) and ROWE score at 12 months: comparison using repeated-
measures ANOVA or non-parametric equivalent where appropriate. 
• 
Time to return to sport: comparison of means between groups. 
• 
Surgical complications: comparison of proportions using Chi-square or Fisher’s 
exact test. 

• 
Graft union rate: comparison using parametric or non-parametric tests as 
appropriate. 
A sensitivity analysis will be performed to assess the impact of missing data or loss to 
follow-up. 
In the intention-to-treat analysis, missing data will be imputed using the last observation 
carried forward method or multiple imputation if losses exceed 5%. 
All statistical analyses will be conducted using SPSS version 18.0 (IBM Inc., Armonk, 
NY, USA). 
Statistical significance will be set at: 
• 
α = 0.025 (one-sided) for the non-inferiority analysis 
• 
α = 0.05 (two-sided) for exploratory and secondary analyses 
 
9. Ethical Considerations 
9.1 General and Specific Investigator Responsibilities 
Investigators will strictly adhere to the provisions of this protocol and will fully complete 
all case report forms. 
The study will be conducted in accordance with: 
• 
Good Clinical Practice (GCP) 
• 
The ethical principles of the Declaration of Helsinki (75th WMA General 
Assembly, Helsinki, Finland, October 2024) 
• 
Spanish Law 14/2007 of July 3 on Biomedical Research 
The processing, communication, and transfer of personal data of all participating patients 
will comply with: 
• 
Regulation (EU) 2016/679 (General Data Protection Regulation – GDPR) 
• 
Spanish Organic Law 3/2018 on Personal Data Protection and Guarantee of 
Digital Rights 
 

9.2 Benefit–Risk Assessment 
Participants may not directly benefit from participation in this study. However, the results 
are expected to contribute to improved knowledge regarding outcomes in patients with 
anterior shoulder instability undergoing the Latarjet procedure and may help prevent 
complications associated with screw fixation. 
Participants will not be exposed to any additional or extraordinary risks, as no extra 
procedures beyond routine clinical practice are planned and the treatment is well 
supported by current scientific literature. 
 
9.3 Informed Consent 
The informed consent document is attached separately to this protocol. 
 
9.4 Data Security and Confidentiality Measures 
Investigators will strictly adhere to this protocol and to Good Clinical Practice guidelines. 
In accordance with clinical trial regulations, the study will be reviewed and approved by 
the Research Ethics Committee with Medicines (CEIm) of Hospital La Paz. 
Only investigators will have access to identifying patient data (initials and medical record 
number). These identifiers will be kept separate from the main study database and will 
not be entered into study datasets. 
Each participant will be identified by a numerical code to ensure confidentiality in 
compliance with Regulation (EU) 2016/679 (GDPR). 
 
10. Data Management 
10.1 Compliance with European/National Legislation 
The sponsor/principal investigator and collaborating team will comply with applicable 
data protection regulations: 
• 
Regulation (EU) 2016/679 (GDPR) 
• 
Spanish Organic Law 3/2018 and related implementing regulations 

 
10.2 Privacy Protection 
All collected information will be treated with strict confidentiality in accordance with 
applicable legislation. 
Data will be pseudonymized, ensuring technical and functional separation between: 
• 
The research team 
• 
Personnel responsible for pseudonymization and re-identification key storage 
Pseudonymized data will be accessible to the research team only after signing 
confidentiality agreements and committing not to attempt re-identification. 
Re-identification may only occur if necessary to protect the safety or health of an 
individual or group, or to ensure appropriate medical care. 
The list linking identification codes to patient identity will be stored confidentially at the 
healthcare institution. 
Access to identifiable data will be restricted to: 
• 
Study investigators and collaborators 
• 
Health authorities (Spanish Agency of Medicines and Medical Devices and 
relevant international authorities) 
• 
Research Ethics Committee (CEIm) 
• 
Inspectors for GCP compliance 
All access will be subject to strict confidentiality obligations. 
 
10.3 Data Access and Use Limitations 
The sponsor/principal investigator will share data only with co-investigators involved in 
the study and reported to the Research Ethics Committee. 
 
11. Biological Sample Management 
Not applicable. 
 

12. Detection, Collection, and Reporting of Adverse Drug Reactions (ADR) 
Not applicable. 
 
13. Timeline 
Months 1–3: Study design and coordination of the working protocol. Submission for 
approval to the Research Ethics Committee with Medicines (CEIm) of Hospital 
Universitario La Paz. 
Months 4–12: Patient recruitment and collection of related study variables. Clinical-
functional and radiological assessment scales will be completed. 
Months 13–24: Analysis of clinical and radiological data. 
Months 24–26: Preparation of a manuscript for publication reporting the study results. 
 
14. Publication and Transparency 
Publication of clinical trial results must meet requirements that ensure transparency, 
integrity, and accessibility of the data obtained. 
14.1 Registration 
Not applicable. 
14.2 Publication of Results 
After completion of the 12-month follow-up period, data analysis will be performed and a 
manuscript will be prepared for publication presenting the study results. This analysis and 
manuscript preparation is expected to take approximately 2 months prior to submission to 
a scientific journal. 
14.3 Data Transparency Policy 
Data will be stored in databases for subsequent evaluation. Data will be retained during 
the conduct of the study and thereafter for a maximum period of 10 years in order to 
comply with any legal obligations that may arise. 

14.4 Communication of Results to Patients and Society 
Results will be published in a high-impact scientific journal accessible to patients and to 
the wider public. 
 
15. Funding 
This study does not receive funding from any public or private entity. 
 
16. Conflict of Interest 
The study investigators declare no conflicts of interest related to the study described.