Rotator Cuff TearsNCT05807854
RSA Vs RCR for Massive RCTs
A study testing Arthroscopy and Reverse Shoulder Arthroplasty in people with Rotator Cuff Tears, run by La Tour Hospital at 2 sites in 2 countries.
Trial summary
Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopy and Reverse Shoulder Arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Patient voluntarily consents to participate
- 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
- 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions
Who cannot join
- 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
- 2 Revision rotator cuff repair
- 3 Patient consent withdrawal
- 4 Glenohumeral arthritis defined as stage > 3 Hamada classification
- 5 Infection and neuropathic joints
- 6 Known or suspected non-compliance, drug or alcohol abuse
Show all 9Show fewer
- 7 Patients incapable of judgement or under tutelage
- 8 Inability to follow the procedures of the study
- 9 Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Patrick Denard, MD
Switzerland1 site, 1 recruiting
- Recruiting
La Tour hospital
Meyrin, Canton of Geneva, 1217
Alexandre Lädermann, MD, +41 22 719 75 55, alexandre.laedermann@gmail.com
About this study
Official title: Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).
Read the detailed description
The majority of degenerative rotator cuff tears occur in individuals over 60 years of age. Therefore, as our population increases in size and advances in age, the incidence of rotator cuff tears is also increasing. A growing number of people are remaining active at this age, and continue to place substantial physical demands on their shoulders notably into their seventh and eighth decades of life. At the same time, the rotator cuff undergoes intrinsic degeneration and the prevalence of osteoporosis increases. Consequently, a significant and growing number of arthroscopic rotator cuff repairs are performed in individuals with poor soft tissue or bone quality. Moreover, whereas most rotator cuff tears occur at the tendon-bone insertion, fixation quality can be challenged by a tear that occurs more medially, leaving only a small amount of tendon for fixation by suture.
Different treatment options are available for massive or irreparable rotator cuff tears, including debridement and subacromial decompression, repair (partial or complete), transfer of the subscapularis tendon, transfer of the teres major muscle, deltoid flap reconstruction, transfer of the latissimus dorsi or the pectoralis major, superior capsule reconstruction, augmented cuff repair, subacromial balloon and reverse total shoulder replacements. None of these treatments has proved superiority on other ones, particularly when the rotator cuff is massively torn.
Massive degenerative rotator ruff tears are a challenge. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. Recently, Liu et al. demonstrated that both rotator cuff repair (RCR) and reverse shoulder arthroplasty (RSA) are effective and reliable options for massive rotator cuff tears (RCT), but revealed a better shoulder function for patients in the rotator cuff repair (RCR) group. While these results are interesting, this study remains retrospective and call for new studies with a higher level of evidence.
The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopy, Reverse Shoulder Arthroplasty
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroscopyProcedure or surgery
The surgeon reattaches the torn tendon to the bone with anchors and sutures.
Reverse Shoulder ArthroplastyDevice
It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic surgery | Active comparator | The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures. Receives: Procedure: Arthroscopy |
| Reverse shoulder arthroplasty | Experimental | The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design). Receives: Device: Reverse Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeon (ASES) score
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Measured: At 24 post-operative months
Secondary outcomes (15)
Pain on Visual Analogue Scale (pVAS)
Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)
Measured: At 24 post-operative months
Constant score
From 0 (worst) to 100 (best)
Measured: At 24 post-operative months
Single Assessment Numeric Evaluation (SANE)
Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)
Measured: At 24 post-operative months
Complication
Any type of post-operative or intra-operative complication
Measured: Within the 24 post-operative months
Location of the defect
(at the foot print | medial cuff failure). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Measured: At 24 post-operative months
Signs of anchor displacement and location
(lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Measured: At 24 post-operative months
Signs of suture cut-through
(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Measured: At 24 post-operative months
Patient satisfaction
Licker scale comprising 7 points
Measured: At 24 post-operative months
Range of motion
Passive and active
Measured: At 24 post-operative months
Tendon defect
According to the Sugaya classification
Measured: At 24 post-operative months
Signs of stem or glenoid loosening
X-ray evaluation
Measured: At 24 post-operative months
Scapular notching
X-ray evaluation
Measured: At 24 post-operative months
Dislocation
X-ray evaluation
Measured: At 24 post-operative months
Acromial fracture
X-ray evaluation
Measured: At 24 post-operative months
Stem subsidence
X-ray evaluation
Measured: At 24 post-operative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- Multicenter, Randomized Comparative Surgical Trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandre Lädermann, La Tour Hospital
- Investigators
- Alexandre Lädermann, MD, Principal investigator, La Tour hospital, Meyrin (1217) Geneva, SwitzerlandPatrick Denard, MD, Principal investigator, Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807854
- Sponsor's protocol ID
- 2023-00111
- Other IDs
- 2023
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Under reasonable request from scientists (with accepted research protocol)
Publications
Ladermann A, Pernoud A, Cochard B, Bothorel H. Treatment of degenerative massive rotator cuff tears: a study protocol for a randomized non-inferiority comparative surgical trial. Trials. 2025 Aug 4;26(1):270. doi: 10.1186/s13063-025-08990-9.
PubMed 40759980
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
- ClinicalTrials.gov ID
- NCT05807854
- Acronym / sponsor ID
- 2023-00111
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 11 Apr 2023 (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.
Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).
Detailed description
The majority of degenerative rotator cuff tears occur in individuals over 60 years of age. Therefore, as our population increases in size and advances in age, the incidence of rotator cuff tears is also increasing. A growing number of people are remaining active at this age, and continue to place substantial physical demands on their shoulders notably into their seventh and eighth decades of life. At the same time, the rotator cuff undergoes intrinsic degeneration and the prevalence of osteoporosis increases. Consequently, a significant and growing number of arthroscopic rotator cuff repairs are performed in individuals with poor soft tissue or bone quality. Moreover, whereas most rotator cuff tears occur at the tendon-bone insertion, fixation quality can be challenged by a tear that occurs more medially, leaving only a small amount of tendon for fixation by suture.
Different treatment options are available for massive or irreparable rotator cuff tears, including debridement and subacromial decompression, repair (partial or complete), transfer of the subscapularis tendon, transfer of the teres major muscle, deltoid flap reconstruction, transfer of the latissimus dorsi or the pectoralis major, superior capsule reconstruction, augmented cuff repair, subacromial balloon and reverse total shoulder replacements. None of these treatments has proved superiority on other ones, particularly when the rotator cuff is massively torn.
Massive degenerative rotator ruff tears are a challenge. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. Recently, Liu et al. demonstrated that both rotator cuff repair (RCR) and reverse shoulder arthroplasty (RSA) are effective and reliable options for massive rotator cuff tears (RCT), but revealed a better shoulder function for patients in the rotator cuff repair (RCR) group. While these results are interesting, this study remains retrospective and call for new studies with a higher level of evidence.
The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, Randomized Comparative Surgical Trial
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic surgery | Active comparator | Procedure: ArthroscopyThe massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures. |
| Reverse shoulder arthroplasty | Experimental | Device: Reverse Shoulder ArthroplastyThe problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1 Patient voluntarily consents to participate
- 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
- 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions
Key exclusion criteria (9 listed)
- 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
- 2 Revision rotator cuff repair
- 3 Patient consent withdrawal
- 4 Glenohumeral arthritis defined as stage > 3 Hamada classification
- 5 Infection and neuropathic joints
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 |
|---|---|---|
| ArthroscopyThe surgeon reattaches the torn tendon to the bone with anchors and sutures. | Procedure or surgery | Arthroscopic surgery |
| Reverse Shoulder ArthroplastyIt consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design). | Device | Reverse shoulder arthroplasty |
Primary outcome
American Shoulder and Elbow Surgeon (ASES) score
Time frame: At 24 post-operative months
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
15 secondary outcomes
Pain on Visual Analogue Scale (pVAS)
Time frame: At 24 post-operative months
Constant score
Time frame: At 24 post-operative months
Single Assessment Numeric Evaluation (SANE)
Time frame: At 24 post-operative months
Complication
Time frame: Within the 24 post-operative months
Location of the defect
Time frame: At 24 post-operative months
Signs of anchor displacement and location
Time frame: At 24 post-operative months
Signs of suture cut-through
Time frame: At 24 post-operative months
Patient satisfaction
Time frame: At 24 post-operative months
Range of motion
Time frame: At 24 post-operative months
Tendon defect
Time frame: At 24 post-operative months
Signs of stem or glenoid loosening
Time frame: At 24 post-operative months
Scapular notching
Time frame: At 24 post-operative months
Dislocation
Time frame: At 24 post-operative months
Acromial fracture
Time frame: At 24 post-operative months
Stem subsidence
Time frame: At 24 post-operative months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 40759980Ladermann A, Pernoud A, Cochard B, Bothorel H. Treatment of degenerative massive rotator cuff tears: a study protocol for a randomized non-inferiority comparative surgical trial. Trials. 2025 Aug 4;26(1):270. doi: 10.1186/s13063-025-08990-9.
- Individual participant dataSharing planned: Undecided. Under reasonable request from scientists (with accepted research protocol)
Related trials for Rotator Cuff Tears
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Not yet recruiting
Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.
Rotator Cuff Tear, Pain Management
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.
Alexandre Lädermann, MD principal investigator
La Tour hospital, Meyrin (1217) Geneva, Switzerland
Patrick Denard, MD principal investigator
Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopy and Reverse Shoulder Arthroplasty in people with Rotator Cuff Tears, run by La Tour Hospital at 2 sites in 2 countries.
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 9 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: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Lädermann, MD (+41 22 71 975 55, alexandre.laedermann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeon (ASES) score (time frame: At 24 post-operative months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05807854, which also lists 1 linked publication.
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 26 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.