An interventional study of reverse shoulder arthroplasty in Rotator Cuff Arthropathy and Glenohumeral Osteoarthritis, sponsored by Yaiza Lopiz Morales. Recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Yaiza Lopiz Morales · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 42 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI
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.
Procedure: reverse shoulder arthroplasty
patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a lateralized center of rotation.
Procedure: reverse shoulder arthroplasty
The patient will be admitted to undergo reconstructive surgery of the arthropathy, by means of one of the two mentioned Inverted Arthroplasty implants. The patient will be operated following always the same surgical technique with the same protocol (position, anesthesia, antibiotic prophylaxis...) and by one of the three surgeons of the shoulder unit, being always at least two of them present in each of the interventions. Both the implants used and the complications occurring during surgery or in the immediate postoperative period will be recorded.
to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.
To compare functional outcomes (Constant scale score) 24 months after surgery in patients over 65 years of age with cuff arthropathies treated with either of two options: Medialized ATHI or lateralized ATHI. the score ranges from 0-100 points. The higher the score the better the functional result
Time frame: 24 Months
Comparison of the results of the visual analog pain scale (VAS)
Comparison of the results obtained in the other functional assessment scale: the visual analog pain scale (VAS).(0-10). The higher the score, the more painful
Time frame: 24 Months
Comparison of Joint Range of Motion between the two prosthetic systems under study.
Comparison of the joint range of motion (joint balance in degrees in abduction, external and internal rotation, anteversion) between the two prosthetic systems under study.
Time frame: 24 Months
Analysis and comparison of the Maximum recorded muscle force.
Maximum muscle force at any time during a repetition. Indicative of muscle force capacity (N-M, newtons per meter).
Time frame: 24 Months
Determination and comparison of the prevalence of complications with each of the prosthetic systems.
Determination and comparison of the prevalence of complications with each of the prosthetic systems used, including radiographic evaluation.
Time frame: 24 Months
Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.
Comparison of the results obtained in the other functional assessment scale: Quick Disabilities of arm, shoulder and hand (Quick-DASH) score. The score ranges from 0 to 100. The higher the score, the greater shoulder disability
Time frame: 24 Months
Comparison of the results of the American Shoulder and Elbow Surgeons score
Comparison of the results obtained in the other functional assessment scales: American Shoulder and Elbow Surgeons score. the the score ranges from 0 to 100, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the greater the score, the lower the level of shoulder disability
Time frame: 24 Months
Analysis and comparison of the Maximum strength as a function of weight
Maximum strength as a function of weight: percentage of muscle strength recorded and normalized by body weight and compared to the set goal ( %).
Time frame: 24 Months
Analysis and comparison of the Total work per repetition
Total work per repetition: total muscle force for the repetition with the greatest amount of work. Work is indicative of the muscle's ability to produce force throughout the range of motion (measured in Joules (J)).
Time frame: 24 Months
Analysis and comparison of the isokinetic parameter (Coefficient of variation )
Coefficient of variation : Statistical representation of the validity of the test based on the reproducibility of the exercise. Low values show higher reproducibility (%).
Time frame: 24 Months
Analysis and comparison of the isokinetic parameters (Average power)
Average power: total work divided by time. Power represents how fast a muscle can produce force (W, watts).
Time frame: 24 Months
Analysis and comparison of the Acceleration rate
Acceleration rate: total time to reach the Isokinetic speed. Indicative of the neuromuscular capacity to move the limb at the beginning of the Range of Motion (msec. milliseconds).
Time frame: 24 Months
Analysis and comparison of the Deceleration speed
Deceleration speed: total time to go from Isokinetic speed to zero speed. Indicative of the neuromuscular capacity to control the limb eccentrically at the end of the Range of Motion (msec, milliseconds).
Time frame: 24 Months
Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)
Agonist/antagonist ratio: The ratio of the reciprocal muscle group. Excessive imbalances may predispose to joint injury.%
Time frame: 24 Months
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