Arthroplasty, Replacement, ShoulderCARS-1NCT06025331
Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
A study testing BIO-RSA and RSA in people with Arthroplasty, Replacement, Shoulder and Shoulder Osteoarthritis, run by Lovisenberg Diakonale Hospital at 2 sites in Norway.
Trial summary
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder, Shoulder Osteoarthritis
- What is being tested?
- BIO-RSA and RSA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesNorway
- Study dates
- 15 Sep 2023to 1 Aug 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
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Lovisenberg Diaconal Hospital
Oslo, 0456
Hanne Fuglø, MSc, 90524172, hanne.fuglo@gmail.com
Kjersti Kaul Jenssen, MD
- Not yet recruiting
Sykehuset Telemark HF
Skien, Telemark, 3710
Birthe Marie Roang-Winjum, MD, +4790665939, birroa@sthf.no
Hilde Apold, MD
About this study
Official title: From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
Read the detailed description
Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complications like limited range of motion (ROM), luxation of the prosthesis, and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. Joint centre lateralization with a bone transplant placed underneath the glenoid component (BIO-RSA) was introduced to maximize ROM in the prosthetic joint, increase stability and to prevent scapular notching. In recent years it has been claimed that lateralization of the COR with BIO-RSA decreases the risk of the aforementioned complication, but no consensus on when or how to lateralize the COR exists as of today. This knowledge will also be of critical importance when it comes to decision making on how these patients are best treated. Results from this research project is expected to have a significant impact on how these patients are treated in the future, both nationally and internationally.
The purpose of this study is to compare functional results between patients with bony increased offset-reversed shoulder arthroplasty (BIO-RSA) and conventional reverse shoulder arthroplasty (RSA) to investigate if lateralization of the glenosphere yields superior outcomes and fewer complications after 2 years.
This multicenter study will include 130 patients in 4 hospitals scheduled for RSA. Patients will be asked to participate in a blinded RCT, where they are randomly assigned to either BIO-RSA or conventional RSA. Functional results will be measured primarily by the patient-reported outcome measure Western Ontario Osteoarthritis Shoulder (WOOS), but they will also be examined by a physiotherapist and CT imagery will be assessed by a radiologist.
- Being tested
- BIO-RSA, RSA
- Keywords
- Reverse Shoulder Arthroplasty, BIO-RSA, 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
Also called Bony increased offset-reversed shoulder arthroplasty
Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.
RSAProcedure or surgery
Also called Reverse shoulder arthroplasty
Conventional reversed shoulder arthroplasty(RSA) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| BIO-RSA | Experimental | Not described Receives: Procedure: BIO-RSA |
| RSA | Active comparator | Not described Receives: Procedure: RSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOOS index from baseline to 24 months postoperatively.
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, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.
Secondary outcomes (7)
Change in EuroQol-5 from baseline to 24 months postoperatively.
The 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.
CT scan
Assessment of bone transplant integration and fixation of the glenoid implant.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in Constant-Murley Score from baseline to 24 months postoperatively.
The Constant-Murley Score (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 physiotherapist.
Measured: Before randomization, 3, 12 and 24 months postoperatively.
Change in range of motion from baseline to 24 months postoperatively.
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 from baseline to 24 months postoperatively.
The Subjective Shoulder Value (SSV) score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of an entirely normal shoulder, which would score 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).
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 start15 Sep 2023
- Primary completion1 Aug 2033 (estimated)
- Study completion1 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, ShoulderStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Sykehuset Telemark, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Sigbjørn Dimmen, PhD, 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
- NCT06025331
- Sponsor's protocol ID
- CARS-1
- Acronym
- CARS-1
- 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
- Individual data sharing
- 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 (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
- ClinicalTrials.gov ID
- NCT06025331
- Acronym / sponsor ID
- CARS-1 / CARS-1
- Keywords
- Reverse Shoulder Arthroplasty, BIO-RSA, Orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Sykehuset Telemark, University Hospital, Akershus
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Aug 2033 (estimated)
- Study completion
- 1 Aug 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.
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
Detailed description
Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complications like limited range of motion (ROM), luxation of the prosthesis, and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. Joint centre lateralization with a bone transplant placed underneath the glenoid component (BIO-RSA) was introduced to maximize ROM in the prosthetic joint, increase stability and to prevent scapular notching. In recent years it has been claimed that lateralization of the COR with BIO-RSA decreases the risk of the aforementioned complication, but no consensus on when or how to lateralize the COR exists as of today. This knowledge will also be of critical importance when it comes to decision making on how these patients are best treated. Results from this research project is expected to have a significant impact on how these patients are treated in the future, both nationally and internationally.
The purpose of this study is to compare functional results between patients with bony increased offset-reversed shoulder arthroplasty (BIO-RSA) and conventional reverse shoulder arthroplasty (RSA) to investigate if lateralization of the glenosphere yields superior outcomes and fewer complications after 2 years.
This multicenter study will include 130 patients in 4 hospitals scheduled for RSA. Patients will be asked to participate in a blinded RCT, where they are randomly assigned to either BIO-RSA or conventional RSA. Functional results will be measured primarily by the patient-reported outcome measure Western Ontario Osteoarthritis Shoulder (WOOS), but they will also be examined by a physiotherapist and CT imagery will be assessed by a radiologist.
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 | Experimental | Procedure: BIO-RSA |
| RSA | Active comparator | Procedure: RSA |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
- 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-RSAAlso: Bony increased offset-reversed shoulder arthroplastyBony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed. | Procedure or surgery | BIO-RSA |
| RSAAlso: Reverse shoulder arthroplastyConventional reversed shoulder arthroplasty(RSA) will be performed. | Procedure or surgery | RSA |
Primary outcome
Change in WOOS index from baseline to 24 months postoperatively.
Time frame: Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.
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.
7 secondary outcomes
Change in EuroQol-5 from baseline to 24 months postoperatively.
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
CT scan
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in Constant-Murley Score from baseline to 24 months postoperatively.
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in range of motion from baseline to 24 months postoperatively.
Time frame: Before randomization, 3, 12 and 24 months postoperatively.
Change in Subjective Shoulder Value from baseline to 24 months postoperatively.
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.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
University of Oslo
Kjersti Kaul Jenssen, PhD principal investigator
Lovisenberg Diaconal Hospital
Christian Owesen, PhD study director
Lovisenberg Diaconal Hospital
2 sites 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 RSA in people with Arthroplasty, Replacement, Shoulder and Shoulder Osteoarthritis, run by Lovisenberg Diakonale Hospital at 2 sites 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 2 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 2 sites 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 Kjersti Kaul Jenssen, PhD (+4790200650, KjerstiKaul.Jenssen@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOOS index from baseline to 24 months postoperatively. (time frame: Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 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; AzTrials last refreshed its copy on 31 Oct 2026.