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

May 3, 2023 updated by: Yaiza Lopiz Morales

Clinical Study to Analyze the Functional, Radiological, and Strength Results in Lateralized Models and Inverted Arthroplasty Medializations

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos de Madrid
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients operated on by means of an inverted shoulder prosthesis with medialized component
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
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.
Active Comparator: patients operated by means of inverted shoulder prosthesis with lateralized component
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.
Time Frame: 24 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the results of the visual analog pain scale (VAS)
Time Frame: 24 Months
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
24 Months
Comparison of Joint Range of Motion between the two prosthetic systems under study.
Time Frame: 24 Months
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.
24 Months
Analysis and comparison of the Maximum recorded muscle force.
Time Frame: 24 Months
Maximum muscle force at any time during a repetition. Indicative of muscle force capacity (N-M, newtons per meter).
24 Months
Determination and comparison of the prevalence of complications with each of the prosthetic systems.
Time Frame: 24 Months
Determination and comparison of the prevalence of complications with each of the prosthetic systems used, including radiographic evaluation.
24 Months
Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.
Time Frame: 24 Months

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
24 Months
Comparison of the results of the American Shoulder and Elbow Surgeons score
Time Frame: 24 Months
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
24 Months
Analysis and comparison of the Maximum strength as a function of weight
Time Frame: 24 Months
Maximum strength as a function of weight: percentage of muscle strength recorded and normalized by body weight and compared to the set goal ( %).
24 Months
Analysis and comparison of the Total work per repetition
Time Frame: 24 Months
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)).
24 Months
Analysis and comparison of the isokinetic parameter (Coefficient of variation )
Time Frame: 24 Months
Coefficient of variation : Statistical representation of the validity of the test based on the reproducibility of the exercise. Low values show higher reproducibility (%).
24 Months
Analysis and comparison of the isokinetic parameters (Average power)
Time Frame: 24 Months
Average power: total work divided by time. Power represents how fast a muscle can produce force (W, watts).
24 Months
Analysis and comparison of the Acceleration rate
Time Frame: 24 Months
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).
24 Months
Analysis and comparison of the Deceleration speed
Time Frame: 24 Months
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).
24 Months
Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)
Time Frame: 24 Months
Agonist/antagonist ratio: The ratio of the reciprocal muscle group. Excessive imbalances may predispose to joint injury.%
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaiza Lopiz Morales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 8, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/016-EC_X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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