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NCT Number: NCT05807854

RSA Vs RCR for Massive RCTs

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).

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Tour hospital, Meyrin, Canton of Geneva, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopy

Procedure

The surgeon reattaches the torn tendon to the bone with anchors and sutures.

Reverse Shoulder Arthroplasty

Device

It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Primary outcomes

  1. 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).

Secondary outcomes

  1. Pain on Visual Analogue Scale (pVAS)

    Time frame: At 24 post-operative months

    Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)

  2. Constant score

    Time frame: At 24 post-operative months

    From 0 (worst) to 100 (best)

  3. Single Assessment Numeric Evaluation (SANE)

    Time frame: At 24 post-operative months

    Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)

  4. Complication

    Time frame: Within the 24 post-operative months

    Any type of post-operative or intra-operative complication

  5. Location of the defect

    Time frame: At 24 post-operative months

    (at the foot print | medial cuff failure). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.

  6. Signs of anchor displacement and location

    Time frame: At 24 post-operative months

    (lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.

  7. Signs of suture cut-through

    Time frame: At 24 post-operative months

    (yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.

  8. Patient satisfaction

    Time frame: At 24 post-operative months

    Licker scale comprising 7 points

  9. Range of motion

    Time frame: At 24 post-operative months

    Passive and active

  10. Tendon defect

    Time frame: At 24 post-operative months

    According to the Sugaya classification

  11. Signs of stem or glenoid loosening

    Time frame: At 24 post-operative months

    X-ray evaluation

  12. Scapular notching

    Time frame: At 24 post-operative months

    X-ray evaluation

  13. Dislocation

    Time frame: At 24 post-operative months

    X-ray evaluation

  14. Acromial fracture

    Time frame: At 24 post-operative months

    X-ray evaluation

  15. Stem subsidence

    Time frame: At 24 post-operative months

    X-ray evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre Lädermann, MD

CONTACT

[email protected]

+41 22 71 975 55

Sponsors and collaborators

Lead sponsor

La Tour Hospital

Other

Registry information

Official study title

Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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