Clinical trial NCT05847062: Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.
Official title: Clinical Study to Analyze the Functional, Radiological, and Strength Results in Lateralized Models and Inverted Arthroplasty Medializations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Arthropathy
Glenohumeral Osteoarthritis
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an experimental, prospective, unblinded, randomized, comparative clinical trial between patients carrying two types of prosthetic implants with a different biomechanical design based on medialization or lateralization of the center of rotation of the inverted prosthesis.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.
timeFrame: 24 Months
Secondary outcomes:
measure: Comparison of the results of the visual analog pain scale (VAS)
timeFrame: 24 Months
measure: Comparison of Joint Range of Motion between the two prosthetic systems under study.
timeFrame: 24 Months
measure: Analysis and comparison of the Maximum recorded muscle force.
timeFrame: 24 Months
measure: Determination and comparison of the prevalence of complications with each of the prosthetic systems.
timeFrame: 24 Months
measure: Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.
timeFrame: 24 Months
measure: Comparison of the results of the American Shoulder and Elbow Surgeons score
timeFrame: 24 Months
measure: Analysis and comparison of the Maximum strength as a function of weight
timeFrame: 24 Months
measure: Analysis and comparison of the Total work per repetition
timeFrame: 24 Months
measure: Analysis and comparison of the isokinetic parameter (Coefficient of variation )
timeFrame: 24 Months
measure: Analysis and comparison of the isokinetic parameters (Average power)
timeFrame: 24 Months
measure: Analysis and comparison of the Acceleration rate
timeFrame: 24 Months
measure: Analysis and comparison of the Deceleration speed
timeFrame: 24 Months
measure: Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)
timeFrame: 24 Months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos de Madrid
Study officials:
References:
citation: Lopiz Y, Garcia-Fernandez C, Arriaza A, Rizo B, Marcelo H, Marco F. Midterm outcomes of bone grafting in glenoid defects treated with reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Sep;26(9):1581-1588. doi: 10.1016/j.jse.2017.01.017. Epub 2017 Apr 10.
citation: Lopiz Y, Rodriguez-Gonzalez A, Martin-Albarran S, Marcelo H, Garcia-Fernandez C, Marco F. Injury to the axillary and suprascapular nerves in rotator cuff arthropathy and after reverse shoulder arthroplasty: a prospective electromyographic analysis. J Shoulder Elbow Surg. 2018 Jul;27(7):1275-1282. doi: 10.1016/j.jse.2017.12.030. Epub 2018 Feb 21.
citation: Garcia-Fernandez C, Lopiz Y, Rizo B, Serrano-Mateo L, Alcobia-Diaz B, Rodriguez-Gonzalez A, Marco F. Reverse total shoulder arhroplasty for the treatment of failed fixation in proximal humeral fractures. Injury. 2018 Sep;49 Suppl 2:S22-S26. doi: 10.1016/j.injury.2018.06.042.
citation: Lopiz Y, Alcobia-Diaz B, Galan-Olleros M, Garcia-Fernandez C, Picado AL, Marco F. Reverse shoulder arthroplasty versus nonoperative treatment for 3- or 4-part proximal humeral fractures in elderly patients: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2019 Dec;28(12):2259-2271. doi: 10.1016/j.jse.2019.06.024. Epub 2019 Sep 6.
citation: Lopiz Y, Garcia-Fernandez C, Vallejo-Carrasco M, Garriguez-Perez D, Achaerandio L, Tesoro-Gonzalo C, Marco F. Reverse shoulder arthroplasty for proximal humeral fracture in the elderly. Cemented or uncemented stem? Int Orthop. 2022 Mar;46(3):635-644. doi: 10.1007/s00264-021-05284-y. Epub 2022 Jan 16.