Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior WearNCT05447819

Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System

A study testing Reverse shoulder arthroplsaty in people with Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
What is being tested?: Reverse shoulder arthroplsaty
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 Aug 2022to 31 Jul 2027
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (>20 degrees posterior wear)
Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation

Who cannot join

Below 50 years of age
Cognitive or linguistic impairment
Insufficient glenoid bone-stock
Previous fracture in the upper extremities
Patients with autoimmune mediated inflammatory arthritis
Glenoid border medial to the medial border of the coracoid on a true AP radiograph

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marie Louise Jensen, MD contact

+4525717963

marie.louise.jensen.02@regionh.dk

Denmark1 site, 1 recruiting

Herlev and Gentofte Hospital
Hellerup, Denmark, 2900
Marie Louise Jensen, MD, +4525717963, marie.louise.jensen.02@regionh.dk
Recruiting

Other trials in Denmark

About this study

This is a randomized controlled trial comparing the DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the standard DELTA Xtend Reverse Shoulder System (control group). All Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear indicating a reverse total shoulder arthroplasty referred to the orthopedic department at Herlev and Gentofte Hospital, Copenhagen University Hospital will be considered for participation in the trial. The following exclude from participation in the study: Below 50 years of age; Cognitive or linguistic impairment; insufficient glenoid bone stock; previous fracture in the upper extremities; autoimmune mediated inflammatory arthritis.A total of 122 patients will be included of which 56 will be part of the roentgen radiostereometric analysis. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the glenoid component and functional outcome by Western Ontario Osteoarthritis of the Shoulder Index (WOOS score). The secondary outcomes are position of arthroplasty, loosening, inferior scapular notching, patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density of the proximal humerus assessed by duel energy x-ray absorptiometry and economy (cost utility analysis). The patients are examined before the operation and 1 week and 3, 6, 12 and 24 months after the operation.

Conditions: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
Being tested: Reverse shoulder arthroplsaty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reverse shoulder arthroplsatyProcedure or surgery
Patients with the diagnosis of rotator cuff arthropathy (degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon) or degeneration of the glenohumeral joint with severe posterior wear with an indication of a reverse total shoulder arthroplasty

Study groups in NCT05447819
Study group	Role	What they receive
DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension	Experimental	By using a lateralized glensphere complications can be reduced and patients can achieve an improved outcome. Currently, little is known about the results of the lateralized design. The initial results have been promising, but migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision Receives: Procedure: Reverse shoulder arthroplsaty
Standard DELTA Xtend Reverse Shoulder System	Active comparator	A design with a standard glenosphere is currently regarded as the standard treatment Receives: Procedure: Reverse shoulder arthroplsaty

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 1 week and at 3 months, 6 months, 1 year and 2 years
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. There will be used 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: preoperatively and at at 3 months, 6 months, 1 year and 2 years

Secondary outcomes (7)

Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ]
There will be used 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
Duel energy x-ray absorptiometry (DXA) [ Time Frame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively ]
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
Constant-Murley score [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ]
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. There will be used 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
Oxford Shoulder Score (OSS) [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ]
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. There will be used 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
Side effects and complications [ Time Frame: 2 years postoperatively ]
There will be recorded 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
Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ]
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
Cost-utility analysis [ Time Frame: 2 years postoperatively ]
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202231 Jul 2027

First posted7 Jul 2022
Study start1 Aug 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (43)Papers the sponsor has linked to this study.
Other trials for Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior WearStudies 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. DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) 2. Standard DELTA Xtend Reverse Shoulder System (control group).
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 122 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05447819
Sponsor's protocol ID: H-21042181
Status last verified: Oct 2024
First submitted: 24 Jun 2022
Last updated: 2 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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 28410836
Andersen 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 27649258
Andersen 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 28918227
ten 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 22383318
Constant 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 18218327
Dawson 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 8682827
Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013 Nov;22(11):1589-98. doi: 10.1016/j.jse.2013.06.017. Epub 2013 Sep 3.
PubMed 24007651
Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
PubMed 22047932
Friedman RJ, Barcel DA, Eichinger JK. Scapular Notching in Reverse Total Shoulder Arthroplasty. J Am Acad Orthop Surg. 2019 Mar 15;27(6):200-209. doi: 10.5435/JAAOS-D-17-00026.
PubMed 30260909
Gluer 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 2294552
Guillemin 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 8263569
Henninger HB, Barg A, Anderson AE, Bachus KN, Burks RT, Tashjian RZ. Effect of lateral offset center of rotation in reverse total shoulder arthroplasty: a biomechanical study. J Shoulder Elbow Surg. 2012 Sep;21(9):1128-35. doi: 10.1016/j.jse.2011.07.034. Epub 2011 Oct 29.
PubMed 22036546
Jensen CL, Petersen MM, Schroder HM, Flivik G, Lund B. Revision total knee arthroplasty with the use of trabecular metal cones: a randomized radiostereometric analysis with 2 years of follow-up. J Arthroplasty. 2012 Dec;27(10):1820-1826.e2. doi: 10.1016/j.arth.2012.04.036. Epub 2012 Jul 13.
PubMed 22795879
Jensen CL, Petersen MM, Schroder HM, Lund B. Bone mineral density changes of the proximal tibia after revision total knee arthroplasty. A randomised study with the use of porous tantalum metaphyseal cones. Int Orthop. 2012 Sep;36(9):1857-63. doi: 10.1007/s00264-012-1601-y. Epub 2012 Jun 26.
PubMed 22733440
Karrholm J, Gill RH, Valstar ER. The history and future of radiostereometric analysis. Clin Orthop Relat Res. 2006 Jul;448:10-21. doi: 10.1097/01.blo.0000224001.95141.fe.
PubMed 16826090

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
ClinicalTrials.gov ID: NCT05447819
Acronym / sponsor ID: H-21042181
Conditions: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 122 participants (estimated)
Lead sponsor: Herlev and Gentofte HospitalUniversity, hospital or other
Collaborators: DePuy Synthes
Study start: 1 Aug 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 7 Jul 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
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. DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) 2. Standard DELTA Xtend Reverse Shoulder System (control group).

Arm	Type	Receives
DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension	Experimental	Procedure: Reverse shoulder arthroplsatyBy using a lateralized glensphere complications can be reduced and patients can achieve an improved outcome. Currently, little is known about the results of the lateralized design. The initial results have been promising, but migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision
Standard DELTA Xtend Reverse Shoulder System	Active comparator	Procedure: Reverse shoulder arthroplsatyA design with a standard glenosphere is currently regarded as the standard treatment

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (>20 degrees posterior wear)
Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation

Key exclusion criteria (6 listed)

Below 50 years of age
Cognitive or linguistic impairment
Insufficient glenoid bone-stock
Previous fracture in the upper extremities
Patients with autoimmune mediated inflammatory arthritis

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
Reverse shoulder arthroplsatyPatients with the diagnosis of rotator cuff arthropathy (degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon) or degeneration of the glenohumeral joint with severe posterior wear with an indication of a reverse total shoulder arthroplasty	Procedure or surgery	DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension, Standard DELTA Xtend Reverse Shoulder System

Primary outcome

Radiostereometric analysis (RSA) [ Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ]
Time frame: At 1 week and at 3 months, 6 months, 1 year and 2 years
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 ]
Time frame: preoperatively and at at 3 months, 6 months, 1 year and 2 years
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. There will be used 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.

7 secondary outcomes

Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ]
Time frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively
Duel energy x-ray absorptiometry (DXA) [ Time Frame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively ]
Time frame: Preoperatively and at 1 week, 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 ]
Time frame: Preoperatively and 3 months, 6 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 ]
Time frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
Side effects and complications [ Time Frame: 2 years postoperatively ]
Time frame: 2 years postoperatively
Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ]
Time frame: 3 months, 6 months, and at 1 and 2 years postoperatively
Cost-utility analysis [ Time Frame: 2 years postoperatively ]
Time frame: 2 years 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 2 Oct 2024.
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 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 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 24007651Denard PJ, Walch G. Current concepts in the surgical management of primary glenohumeral arthritis with a biconcave glenoid. J Shoulder Elbow Surg. 2013 Nov;22(11):1589-98. doi: 10.1016/j.jse.2013.06.017. Epub 2013 Sep 3.
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 30260909Friedman RJ, Barcel DA, Eichinger JK. Scapular Notching in Reverse Total Shoulder Arthroplasty. J Am Acad Orthop Surg. 2019 Mar 15;27(6):200-209. doi: 10.5435/JAAOS-D-17-00026.
Background: PubMed 2294552Gluer 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.
Background: PubMed 8263569Guillemin 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.
Background: PubMed 22036546Henninger HB, Barg A, Anderson AE, Bachus KN, Burks RT, Tashjian RZ. Effect of lateral offset center of rotation in reverse total shoulder arthroplasty: a biomechanical study. J Shoulder Elbow Surg. 2012 Sep;21(9):1128-35. doi: 10.1016/j.jse.2011.07.034. Epub 2011 Oct 29.
Individual participant dataSharing planned: Undecided

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.

Marie Louise Jensen, MD contact

+4525717963

marie.louise.jensen.02@regionh.dk

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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 2 Oct 2024. 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?

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 Marie Louise Jensen, MD (+4525717963, marie.louise.jensen.02@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 ] (time frame: At 1 week and at 3 months, 6 months, 1 year and 2 years). 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 NCT05447819, which also lists 43 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 2 Oct 2024.