Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.

Yaiza Lopiz Morales

Status: Enrolling

Conditions: Rotator Cuff Arthropathy; Glenohumeral Osteoarthritis

Treatments: Procedure: reverse shoulder arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05847062

22/016-EC_X

Details and patient eligibility

About

To determine the functional outcomes, complications and muscle performance by isokinetic study of two reverse arthroplasty systems (one with medialized center of rotation and the other with lateralized center of rotation) in the treatment of rotator cuff arthropathies or irreparable cuff tears.

Full description

This is an experimental, prospective, unblinded, randomized, comparative clinical trial between patients with two types of prosthetic implants (inverted arthroplasty with medialized center of rotation vs inverted arthroplasty with lateralized center of rotation). Those male or female patients who meet the inclusion criteria will be selected to form part of one of the two randomly distributed study groups. Sample size Based on studies with similar characteristics but where lateralization is not performed with the implant but with a bone graft would require a sample size of 34 patients (17 in each group) assuming 20% losses with a Type I error of 0. 05 and a statistical power of 80% to show a difference of 10 points on the Constant scale (the minimal clinically important difference on the Constant scale for reverse arthroplasty is described as 8 points in previous comparative studies so we consider the detection of a difference of 10 to be sufficient. The minimal clinically important difference for function and strength in patients undergoing reverse shoulder arthroplasty. The final N needed would be 42 patients (21 per group). A randomization of patients will be performed to assign them to one or the other study group, which will be carried out by an independent assistant, who will generate a random sequence that will be unknown to the investigators. Each patient will be given a sealed and numbered envelope to choose from, in which the randomized group in which he/she has been included will be determined. The study will be blinded for the patient and rehabilitator but not for the surgeon.

Enrollment: 42 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months.

2. Ability to understand the information sheet, informed consent and evaluation scales.

   Exclusion Criteria:

   Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI

3. Patients in whom another surgical procedure has been associated with ATHI such as a tendon transfer

4. Glenoid bone defects in the horizontal plane (Type B2 and C of the Walch classification) or in the vertical plane (E3 Sirveaux).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

patients operated on by means of an inverted shoulder prosthesis with medialized component

Active Comparator group

Description:

patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a medially rotated center of rotation.

Treatment:

Procedure: reverse shoulder arthroplasty

patients operated by means of inverted shoulder prosthesis with lateralized component

Active Comparator group

Description:

patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a lateralized center of rotation.

Treatment:

Procedure: reverse shoulder arthroplasty