Health TrialsbyHealthPanel

RSA Vs RCR for Massive RCTs

ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorLa Tour Hospital

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arthroscopy

    Procedure/Surgery

    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).

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Arthroscopic surgeryActive comparator 1 intervention
Group B: Reverse shoulder arthroplastyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

American Shoulder and Elbow Surgeon (ASES) score

American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).

Time frame
At 24 post-operative months

Secondary outcomes

1

Pain on Visual Analogue Scale (pVAS)

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

Time frame
At 24 post-operative months
2

Constant score

From 0 (worst) to 100 (best)

Time frame
At 24 post-operative months
3

Single Assessment Numeric Evaluation (SANE)

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

Time frame
At 24 post-operative months
4

Complication

Any type of post-operative or intra-operative complication

Time frame
Within the 24 post-operative months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

La Tour Hospital

Lead sponsor

Source ClinicalTrials.gov
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