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

NCT05847062 | Unknown

• 1 other identifier: 22/016-EC_X
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Arthropathy; Glenohumeral Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  24 Months

Secondary Outcomes (13)

• Comparison of the results of the visual analog pain scale (VAS)

  24 Months

• Comparison of Joint Range of Motion between the two prosthetic systems under study.

  24 Months

• Analysis and comparison of the Maximum recorded muscle force.

  24 Months

• Determination and comparison of the prevalence of complications with each of the prosthetic systems.

  24 Months

• Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.

  24 Months

Study Arms (2)

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

ACTIVE COMPARATOR

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 operated by means of inverted shoulder prosthesis with lateralized component

ACTIVE COMPARATOR

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

Interventions

reverse shoulder arthroplasty PROCEDURE

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.

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months.
• Ability to understand the information sheet, informed consent and evaluation scales.

You may not qualify if:

• Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI
• Patients in whom another surgical procedure has been associated with ATHI such as a tendon transfer
• Glenoid bone defects in the horizontal plane (Type B2 and C of the Walch classification) or in the vertical plane (E3 Sirveaux).

Sponsors & Collaborators

• Yaiza Lopiz Morales: lead

Study Sites (1)

Hospital Clinico San Carlos de Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 28408254 BACKGROUND

• 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.

  PMID: 29475786 BACKGROUND

• 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.

  PMID: 30219143 BACKGROUND

• 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.

  PMID: 31500986 BACKGROUND

• 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.

  PMID: 35034145 BACKGROUND

Central Study Contacts

Yaiza Lopiz Morales, professor

CONTACT

+34 609564029; yaizalopiz@gmail.com

Andres Bartrina, Resident

CONTACT

+34 679202084; a.bartrina16@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients will be randomized to assign them to one or another 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: May 6, 2023
• Study Start: March 8, 2022
• Primary Completion: March 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

ES (1)