Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis
NCT ID: NCT04105478
Last Updated: 2021-08-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
122 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-01
Study Completion Date
2025-02-28
Brief Summary
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This is a randomized controlled trial comparing the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive un-cemented stemmed total shoulder arthroplasty (control group). All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte will be offered participation in the trial. The following exclude from participation in the study: below 18 years of age; cognitive or linguistic impairment; insufficient function of the rotator cuff; poor bone quality and ASA group 4-5. A total of 122 patients will be included of which 56 will be part of radiostereometric analysis (RSA) study of humeral component migration. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the humeral component assessed by RSA. The secondary outcomes are patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost utility analysis). To avoid bias in some of these outcomes, the patient will not know what type of humeral component was used. The patients are examined before the operation and 3, 6, 12 and 24 months after the operation.
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Detailed Description
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Background Osteoarthritis (wear and tear) of the shoulder can, in the most severe cases, require insertion of shoulder prosthesis (an artificial shoulder joint, a total shoulder arthroplasty). This is an effective treatment with pain-relief and significant improvement in shoulder function. A design with a metal stem in the humeral bone canal is currently regarded as the best treatment option, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component stem-related complications can be reduced. Furthermore, the canal preserving design may also facilitate further surgery should the need of a revision prosthesis arise.
Currently, little is known about the results of the stemless design. The initial results have been promising, but as with the stemmed design migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision.
Using radiostereometric analysis (RSA) a special x-ray examination technique based upon insertion of small metal beads into the bone surrounding an implant and attachment of beads to the prosthesis (or using 3-dimensional models of the implant (CAD models) = model-based RSA (MB-RSA)), implant migration can be measured extremely accurate. The RSA technique has previously been used to study migration and loosening of hip and knee prostheses. It has been suggested that RSA should be used to monitor small series of new prostheses the first two years after surgery as a part of a safe phased introduction.
RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function.
Purpose The purpose is to compare the Comprehensive Nano stemless total shoulder prosthesis (intervention group) with the Comprehensive stemmed total shoulder prosthesis (control group).
Method All Danish citizens with shoulder osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte will be offered participation in the trial. The following exclude from participation in the study: below 18 years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff (muscles which stabilize the shoulder joint) and severe co-morbidity (ASA-score 4-5).
A total of 122 patients will be included of which 56 will be part of the RSA analysis. This will allow a maximum of 20% drop out. The study will be conducted as a randomized clinical trial (RCT) where each participant by lot will be allocated to one of the two designs. Patients will subsequently be carefully monitored to determine whether there is a difference. The primary outcome is magnitude and pattern of migration of the humeral component assessed by MB-RSA. The secondary outcomes are pain relief, questionnaires (patient-reported outcome), range of movement and strength (functional outcome), readmission, complications, revisions, changes in bone density round the shoulder assessed by duel energy x-ray absorptiometry (DXA) and economy (cost utility analysis). To avoid bias in some of these outcomes, the patient will not know what type of prosthesis was used. The patients are examined before the operation and 3, 6, 12 and 24 months after the operation. The investigators expect short-term publications of early results at about 2 years after inclusion of the last patient.
Ethical considerations Apart from the differences in design, the two groups are treated alike. Today, the two designs are considered equal in the treatment of osteoarthritis. With this study, all patients are at risk of being treated with a prosthesis that subsequent analyses will deem inferior. This is implicit in the study design and there is nothing a priori to suggest which prosthesis is the better.
The standard treatment at the orthopedic department at Copenhagen University Hospital in Gentofte includes preoperative planning with plain radiographs, CT and MRI scans of the glenohumeral joint and follow-up examinations with plain radiographs postoperatively and at 3 months. In addition to this standard treatment the participating patients will have additional radiographic examinations including:
RSA examination at 1 week, 3 months, 6 months, and at 1 and 2 years: 0.04 mSv Plain radiographs at 1 and 2 years: 0.02 mSv DXA scans preoperatively, at 1 week, 3 months, 6 months, and at 1 and 2 years: 0.04 mSv
The background radiation in Denmark is 3 mSv each year. The extra radiation dosage of 0.10 mSv from this study corresponds to the background radiation during approximately 12 days.
The standard treatment at the orthopedic department at Copenhagen University Hospital in Gentofte includes a follow-up examination at 3 months. The participating patients will have additional follow-up examinations at 1 week, 6 months, and at 1 and 2 years. Besides being time consuming this may maintain the patients in a role of being ill. However, the patients will also have the advantage of feeling secure and any uncertainty or problems can be addressed more easily.
The results of the study should be of benefit to future patients with osteoarthritis of the shoulder and thereby also for the use of resources in healthcare. Neither the coordinating investigator nor participating investigators or surgeons have personal economic interests in the study results.
Currently, little is known about the results of the stemless design. The initial results have been promising, but as with the stemmed design migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision.
Using radiostereometric analysis (RSA) a special x-ray examination technique based upon insertion of small metal beads into the bone surrounding an implant and attachment of beads to the prosthesis (or using 3-dimensional models of the implant (CAD models) = model-based RSA (MB-RSA)), implant migration can be measured extremely accurate. The RSA technique has previously been used to study migration and loosening of hip and knee prostheses. It has been suggested that RSA should be used to monitor small series of new prostheses the first two years after surgery as a part of a safe phased introduction.
RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function.
Purpose The purpose is to compare the Comprehensive Nano stemless total shoulder prosthesis (intervention group) with the Comprehensive stemmed total shoulder prosthesis (control group).
Method All Danish citizens with shoulder osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte will be offered participation in the trial. The following exclude from participation in the study: below 18 years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff (muscles which stabilize the shoulder joint) and severe co-morbidity (ASA-score 4-5).
A total of 122 patients will be included of which 56 will be part of the RSA analysis. This will allow a maximum of 20% drop out. The study will be conducted as a randomized clinical trial (RCT) where each participant by lot will be allocated to one of the two designs. Patients will subsequently be carefully monitored to determine whether there is a difference. The primary outcome is magnitude and pattern of migration of the humeral component assessed by MB-RSA. The secondary outcomes are pain relief, questionnaires (patient-reported outcome), range of movement and strength (functional outcome), readmission, complications, revisions, changes in bone density round the shoulder assessed by duel energy x-ray absorptiometry (DXA) and economy (cost utility analysis). To avoid bias in some of these outcomes, the patient will not know what type of prosthesis was used. The patients are examined before the operation and 3, 6, 12 and 24 months after the operation. The investigators expect short-term publications of early results at about 2 years after inclusion of the last patient.
Ethical considerations Apart from the differences in design, the two groups are treated alike. Today, the two designs are considered equal in the treatment of osteoarthritis. With this study, all patients are at risk of being treated with a prosthesis that subsequent analyses will deem inferior. This is implicit in the study design and there is nothing a priori to suggest which prosthesis is the better.
The standard treatment at the orthopedic department at Copenhagen University Hospital in Gentofte includes preoperative planning with plain radiographs, CT and MRI scans of the glenohumeral joint and follow-up examinations with plain radiographs postoperatively and at 3 months. In addition to this standard treatment the participating patients will have additional radiographic examinations including:
RSA examination at 1 week, 3 months, 6 months, and at 1 and 2 years: 0.04 mSv Plain radiographs at 1 and 2 years: 0.02 mSv DXA scans preoperatively, at 1 week, 3 months, 6 months, and at 1 and 2 years: 0.04 mSv
The background radiation in Denmark is 3 mSv each year. The extra radiation dosage of 0.10 mSv from this study corresponds to the background radiation during approximately 12 days.
The standard treatment at the orthopedic department at Copenhagen University Hospital in Gentofte includes a follow-up examination at 3 months. The participating patients will have additional follow-up examinations at 1 week, 6 months, and at 1 and 2 years. Besides being time consuming this may maintain the patients in a role of being ill. However, the patients will also have the advantage of feeling secure and any uncertainty or problems can be addressed more easily.
The results of the study should be of benefit to future patients with osteoarthritis of the shoulder and thereby also for the use of resources in healthcare. Neither the coordinating investigator nor participating investigators or surgeons have personal economic interests in the study results.
Conditions
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Glenohumeral Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Based on the sample calculation the investigators intend to include a total number of 122 patients of which the first 56 patients will be studied using MB-RSA and DXA. The patients are allocated into two groups of equal of size:
1. The un-cemented Comprehensive Nano stemless shoulder arthroplasty (intervention group)
2. The un-cemented Comprehensive stemmed total shoulder arthroplasty (control group)
The randomization is done in the operating theater just after the perioperative evaluation of the bone-stock and the rotator cuff. The randomization sequence will be computer generated. The patients will be randomized using stratified, block randomization.
1. The un-cemented Comprehensive Nano stemless shoulder arthroplasty (intervention group)
2. The un-cemented Comprehensive stemmed total shoulder arthroplasty (control group)
The randomization is done in the operating theater just after the perioperative evaluation of the bone-stock and the rotator cuff. The randomization sequence will be computer generated. The patients will be randomized using stratified, block randomization.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Un-cemented Comprehensive Nano stemless shoulder arthroplasty
By using a stemless humeral component stem-related complications can be reduced. Furthermore, the canal preserving design may also facilitate further surgery should the need of a revision prosthesis arise.
Currently, little is known about the results of the stemless design. The initial results have been promising, but as with the stemmed design migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision
Group Type
EXPERIMENTAL
Shoulder arthroplasty
Intervention Type
PROCEDURE
Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty
Un-cemented Comprehensive stemmed total shoulder arthroplasty
A design with a metal stem in the humeral bone canal is currently regarded as the best treatment option, but complications related to the stem including humeral fractures can have devastating consequences.
Group Type
ACTIVE_COMPARATOR
Shoulder arthroplasty
Intervention Type
PROCEDURE
Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty
Interventions
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Shoulder arthroplasty
Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte
Exclusion Criteria
* below 18 years of age
* cognitive or linguistic impairment
* insufficient function of the rotator cuff
* poor bone quality
* ASA group 4-5
* cognitive or linguistic impairment
* insufficient function of the rotator cuff
* poor bone quality
* ASA group 4-5
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Herlev and Gentofte Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Marc Randall Kristensen Nyring
Principal investigator, PhD student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Marc Randall Kristensen Nyring
Role: PRINCIPAL_INVESTIGATOR
Herlev and Gentofte Hospital
Locations
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Herlev and Gentofte Hospital
Hellerup, , Denmark
Site Status
RECRUITING
Countries
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Denmark
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
Reference Type
BACKGROUND
Valstar E, Kaptein B, Nelissen R. Radiostereometry and new prostheses. Acta Orthop. 2012 Apr;83(2):103-4. doi: 10.3109/17453674.2012.678796. Epub 2012 Apr 11. No abstract available.
Reference Type
BACKGROUND
Van Thiel GS, Halloran JP, Twigg S, Romeo AA, Nicholson GP. The vertical humeral osteotomy for stem removal in revision shoulder arthroplasty: results and technique. J Shoulder Elbow Surg. 2011 Dec;20(8):1248-54. doi: 10.1016/j.jse.2010.12.013. Epub 2011 Mar 21.
Reference Type
BACKGROUND
Winther NS, Jensen CL, Jensen CM, Lind T, Schroder HM, Flivik G, Petersen MM. Comparison of a novel porous titanium construct (Regenerex(R)) to a well proven porous coated tibial surface in cementless total knee arthroplasty - A prospective randomized RSA study with two-year follow-up. Knee. 2016 Dec;23(6):1002-1011. doi: 10.1016/j.knee.2016.09.010. Epub 2016 Oct 19.
Reference Type
BACKGROUND
Winther N, Jensen C, Petersen M, Lind T, Schroder H, Petersen M. Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study. Int Orthop. 2016 Feb;40(2):285-94. doi: 10.1007/s00264-015-2852-1. Epub 2015 Jul 17.
Reference Type
BACKGROUND
Nyring MRK, Olsen BS, Yilmaz M, Petersen MM, Flivik G, Rasmussen JV. Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis-study protocol for a randomized controlled trial. Trials. 2020 Oct 7;21(1):830. doi: 10.1186/s13063-020-04763-8.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Nano study
Identifier Type: -
Identifier Source: org_study_id
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