Glenohumeral OsteoarthritisNCT04105478
Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis
A study testing Shoulder arthroplasty in people with Glenohumeral Osteoarthritis, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2020to 28 Feb 2025
- 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
- All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte
Who cannot join
- below 18 years of age
- cognitive or linguistic impairment
- insufficient function of the rotator cuff
- poor bone quality
- ASA group 4-5
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Hellerup, 2900
Bo S. Olsen, +4538673280, bo.sanderhoff.olsen@regionh.dk
About this study
Official title: Early Migration of Stemless and Stemmed Humeral Components After Total Shoulder Arthroplasty for Osteoarthritis - A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arthroplastyProcedure or surgery
Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Un-cemented Comprehensive Nano stemless shoulder arthroplasty | Experimental | 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 Receives: Procedure: Shoulder arthroplasty |
| Un-cemented Comprehensive stemmed total shoulder arthroplasty | Active comparator | 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. Receives: Procedure: Shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)). In this way, implant migration can be measured extremely accurate.
Measured: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
Western Ontario Osteoarthritis of the Shoulder index (WOOS)
The WOOS is a disease-specific patient-reported outcome (Lo IK et al 2001). 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 converted to a percentage of the maximum score. We use a Danish version of WOOS (Rasmussen JV et al 2013) which was translated according to the guidelines of Guillemin, Bombardier and Beaton (Guillemin F et al 1993). It was validated with classical test theory in a cohort of patients treated with shoulder arthroplasty for osteoarthritis.
Measured: Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
Secondary outcomes (10)
Duel energy x-ray absorptiometry (DXA)
Changes in bone mineral density (BMD) in close relation to an orthopedic implant can be measured by duel x-ray absorptiometry (DXA)
Measured: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively
Plain radiographs
We use an anterior-posterior and a lateral view. The radiographs are used to evaluate the position of the component and to evaluate loosening as the cause of failure.
Measured: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively
Oxford Shoulder Score (OSS)
Oxford Shoulder Score (OSS): The OSS was conceived as a measurement tool for the assessment of pain and function after elective shoulder surgery (Dawson J et al 1996). There are 12 questions with each item scored from 1-5. The overall score ranges from 12 to 60, with 60 being the worst. For ease of interpretation, the scores are converted to a percentage of the maximum score. We use a Danish version of OSS which was translated and validated with classical test theory (Frich LH et al 2011).
Measured: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
Constant-Murley score
The Constant-Murley Score includes an assessment of: pain; activities of daily living (ADL); range of motion; and strength. There are a possible 35 points given for the subjective assessment of pain and the ability to perform ADL. There are a possible 65 points given for an objective assessment, of which 40 points are allocated to range of motion and 25 points are allocated to strength. The maximum of 100 point indicates a shoulder with no disability. We use a Danish version (Ban I et al 2013) of the modified score described by Con¬stant and colleagues in 2008 (Constant CR et al 2008).
Measured: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
Pain and patient-satisfaction: visual analogue scale (VAS)
Pain is answered on a visual analogue scale (VAS) ranging from 0 to 10, with 10 being the worst. Patients are asked to categorize the result as excellent, very good, good, fair and poor.
Measured: 3 months, 6 months, and at 1 and 2 years postoperatively
Side effects and complications
We will record any case of medical complications (embolism, cardiovascular event, pneumonia) and complications related to the surgical procedure (fractures, nerve injuries, deep and superficial infections, malpositioning of the components, instability, and dislocation) and revisions defined by removal or exchange of any component.
Measured: 2 years postoperatively
Cost-utility analysis
In modern health economics, thresholds have been estimated for acceptable cost-utility ratios - the threshold for how much health care providers will pay for an extra quality- adjusted life year (QALY). In England and in Europe, the threshold for an extra QALY is set at 20,000-30,000 pounds and 30,000 Euros respectively. The cost utility of the Comprehensive Nano stemless shoulder arthroplasty will be compared with these thresholds and with the cost utility of the uncemented Comprehensive stemmed total shoulder arthroplasty. The EQ-5D will be used to estimate QALY for individual patients.
Measured: 2 years postoperatively
Length of hospital stay
How long time the patients are hospitalized postoperatively. The data will be extracted from the medical records.
Measured: 3 months postoperatively
Discharge destination
Whether the patients are discharged to home, rehabilitation or nursing home. The data will be extracted from the medical records.
Measured: 3 months postoperatively
Pain medication usage
Which kind and how much pain medication each patients have used. The data will be extracted from the medical records.
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Mar 2020
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral OsteoarthritisStudies 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Randall Kristensen Nyring, Herlev and Gentofte Hospital
- Investigators
- Marc Randall Kristensen Nyring, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105478
- Sponsor's protocol ID
- Nano study
- Status last verified
- Aug 2021
- First submitted
- 17 Sep 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not the plan to make IPD available to other researchers.
Publications
Andersen MR, Winther NS, Lind T, Schroder HM, Flivik G, Petersen MM. Low Preoperative BMD Is Related to High Migration of Tibia Components in Uncemented TKA-92 Patients in a Combined DEXA and RSA Study With 2-Year Follow-Up. J Arthroplasty. 2017 Jul;32(7):2141-2146. doi: 10.1016/j.arth.2017.02.032. Epub 2017 Feb 28.
PubMed 28410836Andersen MR, Winther N, Lind T, SchroDer H, Flivik G, Petersen MM. Monoblock versus modular polyethylene insert in uncemented total knee arthroplasty. Acta Orthop. 2016 Dec;87(6):607-614. doi: 10.1080/17453674.2016.1233654. Epub 2016 Sep 20.
PubMed 27649258Andersen MR, Winther NS, Lind T, Schroder HM, Mork Petersen M. Bone Remodeling of the Distal Femur After Uncemented Total Knee Arthroplasty-A 2-Year Prospective DXA Study. J Clin Densitom. 2018 Apr-Jun;21(2):236-243. doi: 10.1016/j.jocd.2017.05.001. Epub 2017 Sep 13.
PubMed 28918227Ban I, Troelsen A, Christiansen DH, Svendsen SW, Kristensen MT. Standardised test protocol (Constant Score) for evaluation of functionality in patients with shoulder disorders. Dan Med J. 2013 Apr;60(4):A4608.
PubMed 23651718Barvencik F, Gebauer M, Beil FT, Vettorazzi E, Mumme M, Rupprecht M, Pogoda P, Wegscheider K, Rueger JM, Pueschel K, Amling M. Age- and sex-related changes of humeral head microarchitecture: histomorphometric analysis of 60 human specimens. J Orthop Res. 2010 Jan;28(1):18-26. doi: 10.1002/jor.20957.
PubMed 19630001ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.
PubMed 22383318Brolin TJ, Cox RM, Abboud JA, Namdari S. Stemless Shoulder Arthroplasty: Review of Early Clinical and Radiographic Results. JBJS Rev. 2017 Aug;5(8):e3. doi: 10.2106/JBJS.RVW.16.00096. No abstract available.
PubMed 28763354Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder. A systematic review and meta-analysis. J Bone Joint Surg Am. 2005 Sep;87(9):1947-56. doi: 10.2106/JBJS.D.02854.
PubMed 16140808Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
PubMed 18218327Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600.
PubMed 8682827Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
PubMed 22047932Gartsman GM, Roddey TS, Hammerman SM. Shoulder arthroplasty with or without resurfacing of the glenoid in patients who have osteoarthritis. J Bone Joint Surg Am. 2000 Jan;82(1):26-34. doi: 10.2106/00004623-200001000-00004.
PubMed 10653081Gluer CC, Steiger P, Selvidge R, Elliesen-Kliefoth K, Hayashi C, Genant HK. Comparative assessment of dual-photon absorptiometry and dual-energy radiography. Radiology. 1990 Jan;174(1):223-8. doi: 10.1148/radiology.174.1.2294552.
PubMed 2294552Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.
PubMed 8263569Izquierdo R, Voloshin I, Edwards S, Freehill MQ, Stanwood W, Wiater JM, Watters WC 3rd, Goldberg MJ, Keith M, Turkelson CM, Wies JL, Anderson S, Boyer K, Raymond L, Sluka P; American Academy of Orthopedic Surgeons. Treatment of glenohumeral osteoarthritis. J Am Acad Orthop Surg. 2010 Jun;18(6):375-82. doi: 10.5435/00124635-201006000-00010.
PubMed 20511443
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Migration of Stemless and Stemmed Humeral Components After Total Shoulder Arthroplasty for Osteoarthritis - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04105478
- Acronym / sponsor ID
- Nano study
- Conditions
- Glenohumeral Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Un-cemented Comprehensive Nano stemless shoulder arthroplasty | Experimental | Procedure: Shoulder arthroplastyBy 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 |
| Un-cemented Comprehensive stemmed total shoulder arthroplasty | Active comparator | Procedure: Shoulder arthroplastyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte
Key exclusion criteria (5 listed)
- below 18 years of age
- cognitive or linguistic impairment
- insufficient function of the rotator cuff
- poor bone quality
- ASA group 4-5
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 |
|---|---|---|
| Shoulder arthroplastyPatients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty | Procedure or surgery | Un-cemented Comprehensive Nano stemless shoulder arthroplasty, Un-cemented Comprehensive stemmed total shoulder arthroplasty |
Primary outcome
Radiostereometric analysis (RSA)
Time frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
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)). In this way, implant migration can be measured extremely accurate.
Western Ontario Osteoarthritis of the Shoulder index (WOOS)
Time frame: Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively
The WOOS is a disease-specific patient-reported outcome (Lo IK et al 2001). 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 converted to a percentage of the maximum score. We use a Danish version of WOOS (Rasmussen JV et al 2013) which was translated according to the guidelines of Guillemin, Bombardier and Beaton (Guillemin F et al 1993). It was validated with classical test theory in a cohort of patients treated with shoulder arthroplasty for osteoarthritis.
10 secondary outcomes
Duel energy x-ray absorptiometry (DXA)
Time frame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively
Plain radiographs
Time frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively
Oxford Shoulder Score (OSS)
Time frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
Constant-Murley score
Time frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
Pain and patient-satisfaction: visual analogue scale (VAS)
Time frame: 3 months, 6 months, and at 1 and 2 years postoperatively
Side effects and complications
Time frame: 2 years postoperatively
Cost-utility analysis
Time frame: 2 years postoperatively
Length of hospital stay
Time frame: 3 months postoperatively
Discharge destination
Time frame: 3 months postoperatively
Pain medication usage
Time frame: 2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 28410836Andersen MR, Winther NS, Lind T, Schroder HM, Flivik G, Petersen MM. Low Preoperative BMD Is Related to High Migration of Tibia Components in Uncemented TKA-92 Patients in a Combined DEXA and RSA Study With 2-Year Follow-Up. J Arthroplasty. 2017 Jul;32(7):2141-2146. doi: 10.1016/j.arth.2017.02.032. Epub 2017 Feb 28.
- Background: PubMed 27649258Andersen MR, Winther N, Lind T, SchroDer H, Flivik G, Petersen MM. Monoblock versus modular polyethylene insert in uncemented total knee arthroplasty. Acta Orthop. 2016 Dec;87(6):607-614. doi: 10.1080/17453674.2016.1233654. Epub 2016 Sep 20.
- Background: PubMed 28918227Andersen MR, Winther NS, Lind T, Schroder HM, Mork Petersen M. Bone Remodeling of the Distal Femur After Uncemented Total Knee Arthroplasty-A 2-Year Prospective DXA Study. J Clin Densitom. 2018 Apr-Jun;21(2):236-243. doi: 10.1016/j.jocd.2017.05.001. Epub 2017 Sep 13.
- Background: PubMed 23651718Ban I, Troelsen A, Christiansen DH, Svendsen SW, Kristensen MT. Standardised test protocol (Constant Score) for evaluation of functionality in patients with shoulder disorders. Dan Med J. 2013 Apr;60(4):A4608.
- Background: PubMed 19630001Barvencik F, Gebauer M, Beil FT, Vettorazzi E, Mumme M, Rupprecht M, Pogoda P, Wegscheider K, Rueger JM, Pueschel K, Amling M. Age- and sex-related changes of humeral head microarchitecture: histomorphometric analysis of 60 human specimens. J Orthop Res. 2010 Jan;28(1):18-26. doi: 10.1002/jor.20957.
- Background: PubMed 22383318ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.
- Background: PubMed 28763354Brolin TJ, Cox RM, Abboud JA, Namdari S. Stemless Shoulder Arthroplasty: Review of Early Clinical and Radiographic Results. JBJS Rev. 2017 Aug;5(8):e3. doi: 10.2106/JBJS.RVW.16.00096. No abstract available.
- Background: PubMed 16140808Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder. A systematic review and meta-analysis. J Bone Joint Surg Am. 2005 Sep;87(9):1947-56. doi: 10.2106/JBJS.D.02854.
- Background: PubMed 18218327Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
- Background: PubMed 8682827Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600.
- Background: PubMed 22047932Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
- Background: PubMed 10653081Gartsman GM, Roddey TS, Hammerman SM. Shoulder arthroplasty with or without resurfacing of the glenoid in patients who have osteoarthritis. J Bone Joint Surg Am. 2000 Jan;82(1):26-34. doi: 10.2106/00004623-200001000-00004.
- Individual participant dataSharing planned: No. It is not the plan to make IPD available to other researchers.
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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.
Marc Randall Kristensen Nyring principal investigator
Herlev and Gentofte 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 Shoulder arthroplasty in people with Glenohumeral Osteoarthritis, run by Herlev and Gentofte 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 1 inclusion and 5 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 25 Aug 2021. 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?
Contact Marc Randall Kristensen Nyring (+45 51889121, marc.randall.kristensen.nyring@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometric analysis (RSA) (time frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively). The study lists 2 primary outcomes in all. 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 NCT04105478, which also lists 52 linked publications.
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 25 Aug 2021.