Rotator Cuff ArthropathyNCT05847062
Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.
A study testing reverse shoulder arthroplasty in people with Rotator Cuff Arthropathy and Glenohumeral Osteoarthritis, run by Yaiza Lopiz Morales at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rotator Cuff Arthropathy, Glenohumeral Osteoarthritis
- What is being tested?
- reverse shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos de Madrid
Madrid, 28040
Yaiza Lopiz Morales, Professor, +34 609564029, yaizalopiz@gmail.com
Andres Bartrina Tarrio, Resident, +34679202084, a.bartrina16@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- reverse shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse shoulder arthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Months
Secondary outcomes (13)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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 ( %).
Measured: 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)).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.%
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Mar 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaiza Lopiz Morales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaiza Lopiz Morales, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847062
- Sponsor's protocol ID
- 22/016-EC_X
- Status last verified
- May 2023
- First submitted
- 28 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28408254Lopiz 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.
PubMed 29475786Garcia-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.
PubMed 30219143Lopiz 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.
PubMed 31500986Lopiz 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.
PubMed 35034145
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Analyze the Functional, Radiological, and Strength Results in Lateralized Models and Inverted Arthroplasty Medializations
- ClinicalTrials.gov ID
- NCT05847062
- Acronym / sponsor ID
- 22/016-EC_X
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Yaiza Lopiz MoralesUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients operated on by means of an inverted shoulder prosthesis with medialized component | Active comparator | Procedure: reverse shoulder arthroplastypatients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a medially rotated center of rotation. |
| patients operated by means of inverted shoulder prosthesis with lateralized component | Active comparator | Procedure: reverse shoulder arthroplastypatients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a lateralized center of rotation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reverse shoulder arthroplastyThe 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. | Procedure or surgery | patients operated by means of inverted shoulder prosthesis with lateralized component, patients operated on by means of an inverted shoulder prosthesis with medialized component |
Primary outcome
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
13 secondary outcomes
Comparison of the results of the visual analog pain scale (VAS)
Time frame: 24 Months
Comparison of Joint Range of Motion between the two prosthetic systems under study.
Time frame: 24 Months
Analysis and comparison of the Maximum recorded muscle force.
Time frame: 24 Months
Determination and comparison of the prevalence of complications with each of the prosthetic systems.
Time frame: 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 of the American Shoulder and Elbow Surgeons score
Time frame: 24 Months
Analysis and comparison of the Maximum strength as a function of weight
Time frame: 24 Months
Analysis and comparison of the Total work per repetition
Time frame: 24 Months
Analysis and comparison of the isokinetic parameter (Coefficient of variation )
Time frame: 24 Months
Analysis and comparison of the isokinetic parameters (Average power)
Time frame: 24 Months
Analysis and comparison of the Acceleration rate
Time frame: 24 Months
Analysis and comparison of the Deceleration speed
Time frame: 24 Months
Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 28408254Lopiz 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.
- Background: PubMed 29475786Lopiz 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.
- Background: PubMed 30219143Garcia-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.
- Background: PubMed 31500986Lopiz 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.
- Background: PubMed 35034145Lopiz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reverse shoulder arthroplasty in people with Rotator Cuff Arthropathy and Glenohumeral Osteoarthritis, run by Yaiza Lopiz Morales at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaiza Lopiz Morales, professor (+34 609564029, yaizalopiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI. (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847062, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.