RSA vs RCR for Massive RCTs

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).

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Arthroscopy; Device: Reverse Shoulder Arthroplasty

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Lädermann, MD; Phone Number: +41 22 71 975 55; Email: alexandre.laedermann@gmail.com

Study Locations

• Switzerland
  • Geneva
    • Meyrin, Geneva, Switzerland, 1217
      • Recruiting
      • La Tour Hospital
      • Contact: Alexandre Lädermann, MD; Phone Number: +41 22 719 75 55; Email: alexandre.laedermann@gmail.com
• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Patrick Denard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arthroscopic surgery; The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.	Procedure: Arthroscopy; The surgeon reattaches the torn tendon to the bone with anchors and sutures.
Experimental: Reverse shoulder arthroplasty; 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).	Device: Reverse Shoulder Arthroplasty; It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeon (ASES) score	American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).	At 24 post-operative months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score	From 0 (worst) to 100 (best)	At 24 post-operative months
Complication	Any type of post-operative or intra-operative complication	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.	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.	At 24 post-operative months
Signs of suture cut-through	(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.	At 24 post-operative months
Patient satisfaction	Licker scale comprising 7 points	At 24 post-operative months
Range of motion	Passive and active	At 24 post-operative months
Tendon defect	According to the Sugaya classification	At 24 post-operative months
Signs of stem or glenoid loosening	X-ray evaluation	At 24 post-operative months
Scapular notching	X-ray evaluation	At 24 post-operative months
Dislocation	X-ray evaluation	At 24 post-operative months
Acromial fracture	X-ray evaluation	At 24 post-operative months
Stem subsidence	X-ray evaluation	At 24 post-operative months
Pain on Visual Analogue Scale (pVAS)	Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)	At 24 post-operative months
Single Assessment Numeric Evaluation (SANE)	Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)	At 24 post-operative months

Collaborators and Investigators

• Sponsor: La Tour Hospital
• Investigators: Principal Investigator: Alexandre Lädermann, MD, La Tour hospital, Meyrin (1217) Geneva, Switzerland; Principal Investigator: Patrick Denard, MD, Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): March 1, 2027

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2023-00111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Under reasonable request from scientists (with accepted research protocol)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No