Rotator Cuff ArthropathyRSANCT04809077
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
A study testing Reverse total shoulder replacement in people with Rotator Cuff Arthropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Arthropathy
- What is being tested?
- Reverse total shoulder replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2021to 1 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years old
- Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
- Primary indication for surgery is rotator cuff arthropathy
- Informed consent obtained
Who cannot join
- Total shoulder replacement in post septic arthritis.
- Total shoulder replacement in post-instability arthritis.
- Revision total shoulder arthroplasty.
- Posttraumatic total shoulder arthroplasty (after failed index operation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
Read the detailed description
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
- Conditions
- Rotator Cuff Arthropathy
- Being tested
- Reverse total shoulder replacement
- Keywords
- Reverse total shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse total shoulder replacementOther
Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement
| Study group | Role | What they receive |
|---|---|---|
| Reverse total shoulder replacement | Other | Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) Receives: Other: Reverse total shoulder replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder X-ray
To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al.
Measured: up to 20 months
Secondary outcomes (5)
Clinical outcome
To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome
Measured: up to 20 months
Constant-Murley score
To evaluate the functional state of the shoulder in patients with shoulder complaints
Measured: up to 20 months
Short Form 36 Health Survey Questionnaire (SF-36)
To indicate the health status and pain scales
Measured: up to 20 months
Net Promotor Score (NPS)
To evaluate patient satisfaction after surgery
Measured: one time visit
Anchor Question Shoulder Score
To measure the change in general daily functioning and pain symptoms after shoulder surgery
Measured: up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff ArthropathyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Debeer, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809077
- Sponsor's protocol ID
- S63831
- Acronym
- RSA
- Status last verified
- Jan 2024
- First submitted
- 16 Mar 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
- ClinicalTrials.gov ID
- NCT04809077
- Acronym / sponsor ID
- RSA / S63831
- Conditions
- Rotator Cuff Arthropathy
- Keywords
- Reverse total shoulder arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 22 Mar 2021 (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.
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
Detailed description
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reverse total shoulder replacement | Other | Other: Reverse total shoulder replacementPatients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age of 18 years old
- Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
- Primary indication for surgery is rotator cuff arthropathy
- Informed consent obtained
Key exclusion criteria (4 listed)
- Total shoulder replacement in post septic arthritis.
- Total shoulder replacement in post-instability arthritis.
- Revision total shoulder arthroplasty.
- Posttraumatic total shoulder arthroplasty (after failed index operation)
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 total shoulder replacementLong-term radiographic and clinical data of patients who underwent a reverse shoulder replacement | Other | Reverse total shoulder replacement |
Primary outcome
Shoulder X-ray
Time frame: up to 20 months
To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al.
5 secondary outcomes
Clinical outcome
Time frame: up to 20 months
Constant-Murley score
Time frame: up to 20 months
Short Form 36 Health Survey Questionnaire (SF-36)
Time frame: up to 20 months
Net Promotor Score (NPS)
Time frame: one time visit
Anchor Question Shoulder Score
Time frame: up to 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Arthropathy
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Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
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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.
Philippe Debeer principal investigator
Universitaire Ziekenhuizen KU Leuven
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 total shoulder replacement in people with Rotator Cuff Arthropathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jun 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder X-ray (time frame: up to 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.