Arthroplasty ComplicationsCARS-2NCT06025448
Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?
A study testing BIO-RSA and MIO-RSA in people with Arthroplasty Complications and Shoulder Osteoarthritis, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Arthroplasty Complications, Shoulder Osteoarthritis
- What is being tested?
- BIO-RSA and MIO-RSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 30 Oct 2023to 1 Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
- massive glenoid medialization
- Able to read or write Norwegian
Who cannot join
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid function
- Revision surgery
- ASA IV
- Suspected chronic infection
- Acute fracture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Lovisenberg Diaconal Hospital
Oslo, 0456
Hanne Fuglø, MSc, 90524172, hanne.fuglo@gmail.com
Christian Owesen, MD
About this study
Official title: From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
Read the detailed description
Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. There's several ways to lateralize the glenoid component, a bone transplant placed underneath the glenoid component (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time. Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much comparative literature on metal vs. bony lateralization.
Patients with osteoarthritis and medialization of the glenoid articular surface, who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.
- Being tested
- BIO-RSA, MIO-RSA
- Keywords
- Reverse shoulder arthroplasty, BIO-RSA, MIO-RSA, Bony lateralization, Metallic lateralization, Orthopedic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-RSAProcedure or surgery
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).
MIO-RSAProcedure or surgery
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).
| Study group | Role | What they receive |
|---|---|---|
| BIO-RSA | Active comparator | Not described Receives: Procedure: BIO-RSA |
| MIO-RSA | Experimental | Not described Receives: Procedure: MIO-RSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of glenoid component from baseline until 24 months
CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.
The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner)
CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.
Measured: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.
Secondary outcomes (7)
Change in WOOS Index
The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis.
There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are often converted to a percentage of the maximum score.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in Constant-Murley Score
The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The test is divided into subjective and objective components. Two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65.
Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in EuroQol-5
he widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life.
The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 -100, higher levels indicate better self-rated health.
The descriptive system can be converted to a single summary index number where lower levels indicate poorer health related quality of life.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in range of motion
The patient's active and passive range of motion (ROM) in the affected shoulder will be measured by an experienced physiotherapist with a long-legged goniometer. The directions measured will be flexion, abduction, external rotation and internal rotation, measured in degrees and/or physical landmarks.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in Subjective Shoulder Value
The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Anchor Question 1
This anchor question is asked to help determine Patient Acceptable Symptom State (PASS).
"Considering all daily activities that involves your operated shoulder, your level of pain and degree of function, how satisfied are you with the condition of your shoulder is right now?" Alternatives: Satisfied/somewhat satisfied/Neither satisfied or unsatisfied/somewhat unsatisfied/Unsatisfied
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Anchor Question 2
This anchor question is asked to help determine Minimal Important Difference (MID) and Substantial Clinical Benefit (SCB).
"Think of all the ways your operated shoulder has affected you the last week. Since your surgery, has there been any change in the condition of your shoulder that you would consider important or meaningful to you?" Alternatives: Much better/moderately better/a bit better/no change/a bit worse/moderately worse/Much worse
Measured: 3, 12 and 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start30 Oct 2023
- Primary completion1 Mar 2033 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigbjørn Dimmen, Prof., Principal investigator, University of OsloKjersti Kaul Jenssen, PhD, Principal investigator, Lovisenberg Diaconal HospitalChristian Owesen, PhD, Study director, Lovisenberg Diaconal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025448
- Sponsor's protocol ID
- CARS-2
- Acronym
- CARS-2
- Status last verified
- Nov 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).
- ClinicalTrials.gov ID
- NCT06025448
- Acronym / sponsor ID
- CARS-2 / CARS-2
- Keywords
- Reverse shoulder arthroplasty, BIO-RSA, MIO-RSA, Bony lateralization, Metallic lateralization, Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Mar 2033 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 6 Sep 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.
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
Detailed description
Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. There's several ways to lateralize the glenoid component, a bone transplant placed underneath the glenoid component (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time. Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much comparative literature on metal vs. bony lateralization.
Patients with osteoarthritis and medialization of the glenoid articular surface, who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIO-RSA | Active comparator | Procedure: BIO-RSA |
| MIO-RSA | Experimental | Procedure: MIO-RSA |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
- massive glenoid medialization
- Able to read or write Norwegian
Key exclusion criteria (8 listed)
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid function
- Revision surgery
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 |
|---|---|---|
| BIO-RSAPatients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA). | Procedure or surgery | BIO-RSA |
| MIO-RSAPatients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA). | Procedure or surgery | MIO-RSA |
Primary outcome
Migration of glenoid component from baseline until 24 months
Time frame: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.
CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation. The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner) CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.
7 secondary outcomes
Change in WOOS Index
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in Constant-Murley Score
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in EuroQol-5
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in range of motion
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in Subjective Shoulder Value
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Anchor Question 1
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Anchor Question 2
Time frame: 3, 12 and 24 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Sigbjørn Dimmen, Prof. principal investigator
University of Oslo
Kjersti Kaul Jenssen, PhD principal investigator
Lovisenberg Diaconal Hospital
Christian Owesen, PhD study director
Lovisenberg Diaconal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIO-RSA and MIO-RSA in people with Arthroplasty Complications and Shoulder Osteoarthritis, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 Nov 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Owesen, PhD (+4790515843, cow@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration of glenoid component from baseline until 24 months (time frame: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.). 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 7 Nov 2023.