Shoulder PainNCT03877315
Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.
A study testing Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. and Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. in people with Shoulder Pain and Shoulder Osteoarthritis, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis
- What is being tested?
- Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. and Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to 1 Aug 2023
- 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
- Patients aged ≥ 18 years.
- Patients have been referred to the Orthopedic Department or Zealand University Hospital, Koege or Hvidovre University Hospital for shoulder pain during the study period.
- Patients have the ability to read trial information in Danish and give informed consent.
- The diagnosis will be based on plain radiographs (at least two perpendicular views), reduction of joint space, and/or osteophyte formation.
- Clinical presentation with pain at night and/or daily pain, pain in overhead activity, and consumption of pain medication.
Who cannot join
- Previous shoulder surgery that involves the humeral head and/or the glenoid cavity.
- Patients with alcohol or drug abuse problems that can compromise rehabilitation and follow-up appointments as assessed by the recruiting surgeon at the first visit.
- Patients unable to understand instructions in Danish, follow the rehabilitation protocol, or answer the questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon at the first visit.
- Brachial plexus palsy.
- Patients with previous fractures around the shoulder (clavicle, scapula, and proximal humerus fractures).
- Patients with MRI scan-verified full thickness total tear of one or more of the rotator cuff tendons.
- Patients with CT scan-verified glenoid retroversion ≥ 20° that does not allow glenoid component fixation without bone graft or need an augmented glenoid component.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis: a Patient Blinded Randomized Clinical Trial
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock, and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty.
Read the detailed description
Glenohumeral joint osteoarthritis is a common cause of shoulder pain, affecting up to one-third of patients older than 60 years. Surgical treatment is indicated for patients with glenohumeral arthritis who continue to experience significant symptoms despite an appropriate course of non-operative management. Shoulder arthroplasty accounts for the third most common joint replacement procedure after the hip and knee arthroplasty. Based on data from the National Patient Registry, The Statistical Department of the Danish National Board of Health, the use of primary shoulder replacement in Denmark increased from 12 replacements per 100,000 inhabitants in 2005 to 19 replacements per 100,000 inhabitants in 2015. Glenohumeral osteoarthritis is now the most common indication for shoulder arthroplasty in Denmark.
Many different shoulder arthroplasty designs are available on the market. The stemless shoulder arthroplasty system with uncemented metaphyseal fixation has been used in Europe for glenohumeral osteoarthritis since 2004. The indications for anatomical stemless TSA are the same as for anatomical stemmed TSA: osteoarthritis, rheumatoid arthritis, and post-traumatic osteoarthritis or osteonecrosis.
The contraindications for anatomical stemless TSA are acute proximal humerus fracture, inadequate metaphyseal bone stock, and rotator cuff insufficiency.
Stemless TSA has several theoretical advantages over stemmed TSA: restoring patients' anatomy (humeral shaft angle, humeral head diameter, and lateralization); preserving humeral bone stock, and few complications in component removal should the need of a revision arthroplasty arise. A recent review of 3,360 anatomical total shoulder arthroplasties found an overall complication rate of 10.3%. Periprosthetic fractures accounted for 6.7% and humeral component loosening for 1.4% of all complications. Complications related to the stemmed humeral component can be divided into intraoperative (malpositioning, false route, periprosthetic fracture) and postoperative (loosening, migration, disassembly, periprosthetic fracture, stem fracture) complications. When a revision is necessary because of infection or periprosthetic fracture, the removal of a well-fixed or cemented humeral component can be challenging and lead to bone damage.
Few outcome studies on stemless TSA are available. A recent review of 11 observational studies (published 2010-2016), incorporating a total of 929 patients, reported comparable short- and midterm functional outcomes between stemmed and stemless shoulder prosthesis. Otherwise, there are few well-conducted and adequately powered clinical studies.
The objective of this study is to increase knowledge about shoulder function after operation with anatomical TSA by comparing the patient-reported outcome after stemmed and stemless anatomical TSA for glenohumeral osteoarthritis.
- Conditions
- Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis
- Being tested
- Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System., Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.Device
A total shoulder prosthesis used in treating glenohumeral osteoarthritis
Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.Device
A total shoulder prosthesis used in treating glenohumeral osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Stemmed | Active comparator | Subjects operated with stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. Receives: Device: Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. |
| Non-Stemmed | Active comparator | Subjects operated with stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. Receives: Device: Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)
The WOOS is a patient-administered, disease-specific ques¬tionnaire for measurement of the quality of life of patients with osteoarthritis. It provides scores for four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions. Patients answer each question using the visual analogue scale. The WOOS score is calculated by measuring the distance from the left side of the line and calculating the possible score ranging from 0 to 100 (recorded to the nearest 0.5 mm.) It consists of 19 questions, and the total score ranges from 0 to 1900. A maximum score of 1900 signifies that the patient has an extreme decrease in shoulder-related quality of life, whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life. The questionnaire has been translated into Danish and validated and tested on patients with shoulder osteoarthritis.
Measured: 12 months after surgery
Secondary outcomes (3)
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)
Measured: 3 months after surgery
Oxford Shoulder Score (OSS)
Oxford Shoulder Score (OSS) is a measurement tool for the assessment of outcomes of shoulder surgery. It has been tested and validated in patients with primary or secondary osteoarthritis. The OSS is a 12-item questionnaire, with each item scored from 0-4; thus, the overall score is the sum of the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms) to 48 (least severe symptoms). For simplicity of presentation, the raw scores will be converted to a percentage of the maximum score. We will use a validated Danish version.
Measured: 3 and 12 months after surgery
EQ-5D questionnaire
The EQ-5D, the health status component of the EuroQol assessment (EuroQol Group, Rotterdam, The Netherlands), is a generic instrument for describing and evaluating health-related quality of life. The EuroQol instrument has been designed for self-completion by the respondent.
The EQ-5D is a descriptive system comprising five dimensions in each of which the respondents describe their health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient choose one of five levels for each dimension, and thus a five-digit number (EuroQol Group 1990) can define the resulting health state. We received permission to use the Danish version (permission ID number 27296).
Measured: 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Aug 2019
- Primary completion28 Feb 2022
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Zaid Issa, Zealand University Hospital
- Investigators
- Zaid Issa, MD, Principal investigator, Zealand University Hospital Koege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877315
- Sponsor's protocol ID
- REG-106-2018
- Status last verified
- Dec 2022
- First submitted
- 12 Mar 2019
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Issa Z, Rasmussen JV, Petersen JK, Schantz K, Brorson S. Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial. Trials. 2019 Jul 12;20(1):427. doi: 10.1186/s13063-019-3535-9.
PubMed 31300025
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis: a Patient Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03877315
- Acronym / sponsor ID
- REG-106-2018
- Conditions
- Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 15 Mar 2019 (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.
Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock, and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty.
Detailed description
Glenohumeral joint osteoarthritis is a common cause of shoulder pain, affecting up to one-third of patients older than 60 years. Surgical treatment is indicated for patients with glenohumeral arthritis who continue to experience significant symptoms despite an appropriate course of non-operative management. Shoulder arthroplasty accounts for the third most common joint replacement procedure after the hip and knee arthroplasty. Based on data from the National Patient Registry, The Statistical Department of the Danish National Board of Health, the use of primary shoulder replacement in Denmark increased from 12 replacements per 100,000 inhabitants in 2005 to 19 replacements per 100,000 inhabitants in 2015. Glenohumeral osteoarthritis is now the most common indication for shoulder arthroplasty in Denmark.
Many different shoulder arthroplasty designs are available on the market. The stemless shoulder arthroplasty system with uncemented metaphyseal fixation has been used in Europe for glenohumeral osteoarthritis since 2004. The indications for anatomical stemless TSA are the same as for anatomical stemmed TSA: osteoarthritis, rheumatoid arthritis, and post-traumatic osteoarthritis or osteonecrosis.
The contraindications for anatomical stemless TSA are acute proximal humerus fracture, inadequate metaphyseal bone stock, and rotator cuff insufficiency.
Stemless TSA has several theoretical advantages over stemmed TSA: restoring patients' anatomy (humeral shaft angle, humeral head diameter, and lateralization); preserving humeral bone stock, and few complications in component removal should the need of a revision arthroplasty arise. A recent review of 3,360 anatomical total shoulder arthroplasties found an overall complication rate of 10.3%. Periprosthetic fractures accounted for 6.7% and humeral component loosening for 1.4% of all complications. Complications related to the stemmed humeral component can be divided into intraoperative (malpositioning, false route, periprosthetic fracture) and postoperative (loosening, migration, disassembly, periprosthetic fracture, stem fracture) complications. When a revision is necessary because of infection or periprosthetic fracture, the removal of a well-fixed or cemented humeral component can be challenging and lead to bone damage.
Few outcome studies on stemless TSA are available. A recent review of 11 observational studies (published 2010-2016), incorporating a total of 929 patients, reported comparable short- and midterm functional outcomes between stemmed and stemless shoulder prosthesis. Otherwise, there are few well-conducted and adequately powered clinical studies.
The objective of this study is to increase knowledge about shoulder function after operation with anatomical TSA by comparing the patient-reported outcome after stemmed and stemless anatomical TSA for glenohumeral osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stemmed | Active comparator | Device: Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.Subjects operated with stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. |
| Non-Stemmed | Active comparator | Device: Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.Subjects operated with stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years.
- Patients have been referred to the Orthopedic Department or Zealand University Hospital, Koege or Hvidovre University Hospital for shoulder pain during the study period.
- Patients have the ability to read trial information in Danish and give informed consent.
- The diagnosis will be based on plain radiographs (at least two perpendicular views), reduction of joint space, and/or osteophyte formation.
- Clinical presentation with pain at night and/or daily pain, pain in overhead activity, and consumption of pain medication.
Key exclusion criteria (7 listed)
- Previous shoulder surgery that involves the humeral head and/or the glenoid cavity.
- Patients with alcohol or drug abuse problems that can compromise rehabilitation and follow-up appointments as assessed by the recruiting surgeon at the first visit.
- Patients unable to understand instructions in Danish, follow the rehabilitation protocol, or answer the questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon at the first visit.
- Brachial plexus palsy.
- Patients with previous fractures around the shoulder (clavicle, scapula, and proximal humerus fractures).
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 |
|---|---|---|
| Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.A total shoulder prosthesis used in treating glenohumeral osteoarthritis | Device | Stemmed |
| Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.A total shoulder prosthesis used in treating glenohumeral osteoarthritis | Device | Non-Stemmed |
Primary outcome
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)
Time frame: 12 months after surgery
The WOOS is a patient-administered, disease-specific ques¬tionnaire for measurement of the quality of life of patients with osteoarthritis. It provides scores for four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions. Patients answer each question using the visual analogue scale. The WOOS score is calculated by measuring the distance from the left side of the line and calculating the possible score ranging from 0 to 100 (recorded to the nearest 0.5 mm.) It consists of 19 questions, and the total score ranges from 0 to 1900. A maximum score of 1900 signifies that the patient has an extreme decrease in shoulder-related quality of life, whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life. The questionnaire has been translated into Danish and validated and tested on patients with shoulder osteoarthritis.
3 secondary outcomes
Western Ontario Osteoarthritis of the Shoulder Score (WOOS)
Time frame: 3 months after surgery
Oxford Shoulder Score (OSS)
Time frame: 3 and 12 months after surgery
EQ-5D questionnaire
Time frame: 3 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 31300025Issa Z, Rasmussen JV, Petersen JK, Schantz K, Brorson S. Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial. Trials. 2019 Jul 12;20(1):427. doi: 10.1186/s13063-019-3535-9.
- 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. This study is not recruiting at the moment.
Zaid Issa, MD principal investigator
Zealand University Hospital Koege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System. and Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System. in people with Shoulder Pain and Shoulder Osteoarthritis, run by Zealand University Hospital at 1 site in Denmark.
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 5 inclusion and 7 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 22 Dec 2022. 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 Denmark. 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?
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?
Western Ontario Osteoarthritis of the Shoulder Score (WOOS) (time frame: 12 months after surgery). 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 NCT03877315, which also lists 1 linked publication.
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 22 Dec 2022.