- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447819
Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
August 2, 2022 updated by: Marie Louise Jensen, Herlev and Gentofte Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie Louise Jensen, MD
- Phone Number: +4525717963
- Email: marie.louise.jensen.02@regionh.dk
Study Locations
-
-
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Hellerup, Denmark, 2900
- Recruiting
- Herlev and Gentofte Hospital
-
Contact:
- Marie Louise Jensen, MD
- Phone Number: +4525717963
- Email: marie.louise.jensen.02@regionh.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension
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 |
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
|
Active Comparator: Standard DELTA Xtend Reverse Shoulder System
A design with a standard glenosphere is currently regarded as the standard treatment
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 ]
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.
|
preoperatively and at at 3 months, 6 months, 1 year and 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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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
|
Changes in bone mineral density (BMD) in close relation to an orthopedic implant can be measured by duel x-ray absorptiometry (DXA)
|
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
|
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).
|
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
|
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).
|
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
|
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.
|
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
|
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.
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3 months, 6 months, and at 1 and 2 years postoperatively
|
Cost-utility analysis [ Time Frame: 2 years postoperatively ]
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.
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2 years postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nelissen RG, Pijls BG, Karrholm J, Malchau H, Nieuwenhuijse MJ, Valstar ER. RSA and registries: the quest for phased introduction of new implants. J Bone Joint Surg Am. 2011 Dec 21;93 Suppl 3:62-5. doi: 10.2106/JBJS.K.00907.
- 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.
- 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.
- Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Mole D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004 Apr;86(3):388-95. doi: 10.1302/0301-620x.86b3.14024.
- 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.
- 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.
- Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
- 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.
- 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.
- 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.
- 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.
- Karrholm J. Radiostereometric analysis of early implant migration - a valuable tool to ensure proper introduction of new implants. Acta Orthop. 2012 Dec;83(6):551-2. doi: 10.3109/17453674.2012.745352. Epub 2012 Nov 5. No abstract available.
- Laursen MB, Nielsen PT, Soballe K. Bone remodelling around HA-coated acetabular cups : a DEXA study with a 3-year follow-up in a randomised trial. Int Orthop. 2007 Apr;31(2):199-204. doi: 10.1007/s00264-006-0148-1. Epub 2006 Jun 8.
- Lawrence C, Williams GR, Namdari S. Influence of Glenosphere Design on Outcomes and Complications of Reverse Arthroplasty: A Systematic Review. Clin Orthop Surg. 2016 Sep;8(3):288-97. doi: 10.4055/cios.2016.8.3.288. Epub 2016 Aug 10.
- Lo IK, Griffin S, Kirkley A. The development of a disease-specific quality of life measurement tool for osteoarthritis of the shoulder: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Osteoarthritis Cartilage. 2001 Nov;9(8):771-8. doi: 10.1053/joca.2001.0474.
- Marchetti ME, Houde JP, Steinberg GG, Crane GK, Goss TP, Baran DT. Humeral bone density losses after shoulder surgery and immobilization. J Shoulder Elbow Surg. 1996 Nov-Dec;5(6):471-6. doi: 10.1016/s1058-2746(96)80020-6.
- Mazess RB, Barden HS. Measurement of bone by dual-photon absorptiometry (DPA) and dual-energy X-ray absorptiometry (DEXA). Ann Chir Gynaecol. 1988;77(5-6):197-203.
- Mechlenburg I, Klebe TM, Dossing KV, Amstrup A, Soballe K, Stilling M. Evaluation of periprosthetic bone mineral density and postoperative migration of humeral head resurfacing implants: two-year results of a randomized controlled clinical trial. J Shoulder Elbow Surg. 2014 Oct;23(10):1427-36. doi: 10.1016/j.jse.2014.05.012.
- Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of scapular notching on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 476 shoulders. J Shoulder Elbow Surg. 2017 Jul;26(7):1253-1261. doi: 10.1016/j.jse.2016.11.043. Epub 2017 Jan 19.
- Nuttall D, Haines JF, Trail IA. The early migration of a partially cemented fluted pegged glenoid component using radiostereometric analysis. J Shoulder Elbow Surg. 2012 Sep;21(9):1191-6. doi: 10.1016/j.jse.2011.07.028. Epub 2011 Nov 1.
- Nuttall D, Birch A, Haines JF, Trail IA. Radiostereographic analysis of a shoulder surface replacement: does hydroxyapatite have a place? Bone Joint J. 2014 Aug;96-B(8):1077-81. doi: 10.1302/0301-620X.96B8.30534.
- Nuttall D, Haines JF, Trail II. A study of the micromovement of pegged and keeled glenoid components compared using radiostereometric analysis. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S65-70. doi: 10.1016/j.jse.2006.01.015. Epub 2006 Aug 7.
- Rasmussen JV, Jakobsen J, Olsen BS, Brorson S. Translation and validation of the Western Ontario Osteoarthritis of the Shoulder (WOOS) index - the Danish version. Patient Relat Outcome Meas. 2013 Sep 18;4:49-54. doi: 10.2147/PROM.S50976. eCollection 2013.
- Rasmussen JV, Olsen BS, Sorensen AK, Hrobjartsson A, Brorson S. Resurfacing hemiarthroplasty compared to stemmed hemiarthroplasty for glenohumeral osteoarthritis: a randomised clinical trial. Int Orthop. 2015 Feb;39(2):263-9. doi: 10.1007/s00264-014-2505-9. Epub 2014 Aug 27.
- Rasmussen JV, Hole R, Metlie T, Brorson S, Aarimaa V, Demir Y, Salomonsson B, Jensen SL. Anatomical total shoulder arthroplasty used for glenohumeral osteoarthritis has higher survival rates than hemiarthroplasty: a Nordic registry-based study. Osteoarthritis Cartilage. 2018 May;26(5):659-665. doi: 10.1016/j.joca.2018.02.896. Epub 2018 Feb 21.
- Rasmussen JV, Olsen BS, Al-Hamdani A, Brorson S. Outcome of Revision Shoulder Arthroplasty After Resurfacing Hemiarthroplasty in Patients with Glenohumeral Osteoarthritis. J Bone Joint Surg Am. 2016 Oct 5;98(19):1631-1637. doi: 10.2106/JBJS.15.00934.
- Rasmussen JV, Polk A, Brorson S, Sorensen AK, Olsen BS. Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis. 1,209 cases from the Danish Shoulder Arthroplasty Registry, 2006-2010. Acta Orthop. 2014 Apr;85(2):117-22. doi: 10.3109/17453674.2014.893497.
- Rasmussen JV, Polk A, Sorensen AK, Olsen BS, Brorson S. Outcome, revision rate and indication for revision following resurfacing hemiarthroplasty for osteoarthritis of the shoulder: 837 operations reported to the Danish Shoulder Arthroplasty Registry. Bone Joint J. 2014 Apr;96-B(4):519-25. doi: 10.1302/0301-620X.96B4.31850.
- Roche CP, Stroud NJ, Martin BL, Steiler CA, Flurin PH, Wright TW, DiPaola MJ, Zuckerman JD. The impact of scapular notching on reverse shoulder glenoid fixation. J Shoulder Elbow Surg. 2013 Jul;22(7):963-70. doi: 10.1016/j.jse.2012.10.035. Epub 2013 Jan 16.
- Stilling M, Mechlenburg I, Amstrup A, Soballe K, Klebe T. Precision of novel radiological methods in relation to resurfacing humeral head implants: assessment by radiostereometric analysis, DXA, and geometrical analysis. Arch Orthop Trauma Surg. 2012 Nov;132(11):1521-30. doi: 10.1007/s00402-012-1580-x. Epub 2012 Jul 7.
- Ten Brinke B, Beumer A, Koenraadt KLM, Eygendaal D, Kraan GA, Mathijssen NMC. The accuracy and precision of radiostereometric analysis in upper limb arthroplasty. Acta Orthop. 2017 Jun;88(3):320-325. doi: 10.1080/17453674.2017.1291872. Epub 2017 Mar 2.
- Trozzi C, Kaptein BL, Garling EH, Shelyakova T, Russo A, Bragonzoni L, Martelli S. Precision assessment of model-based RSA for a total knee prosthesis in a biplanar set-up. Knee. 2008 Oct;15(5):396-402. doi: 10.1016/j.knee.2008.05.001. Epub 2008 Jul 16.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
July 31, 2025
Study Completion (Anticipated)
July 31, 2026
Study Registration Dates
First Submitted
June 24, 2022
First Submitted That Met QC Criteria
July 6, 2022
First Posted (Actual)
July 7, 2022
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-21042181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Encore Medical, L.P.Enrolling by invitationSevere Arthropathy With a Grossly Deficient Rotator CuffUnited States
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Limacorporate S.p.aActive, not recruitingRheumatoid Arthritis | Post-traumatic; Arthrosis | Primary Osteoarthritis | Secondary Osteoarthritis | Rotator Cuff Tear Arthropathy | Avascular Necrosis of the Head of HumerusGermany, Netherlands, United Kingdom
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DePuy InternationalTerminatedRheumatoid Arthritis | Cuff Tear Arthropathy | Osteoarthritis With Cuff Deficiency | Post Traumatic Injury to Shoulder | Revision Surgery of a Failed Anatomic Shoulder ProsthesisFrance, Belgium, Germany
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Zimmer BiometActive, not recruitingOsteoarthritis of the Shoulder | Post-Traumatic Arthritis | Arthropathy of Shoulder Region | Grossly Deficient Rotator Cuff | Rheumatoid Arthritis Without Humeral Metaphyseal DefectsUnited States
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Stryker Trauma GmbHRecruitingRotator Cuff Tears | Shoulder Deformity | Osteoarthritis Shoulder | Avascular Necrosis of the Head of Humerus | Rheumatoid Arthritis Shoulder | Fracture, Humeral | Traumatic Arthritis of Right Shoulder Region (Diagnosis)United States
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Cure CMDRecruitingEmery-Dreifuss Muscular Dystrophy | Congenital Myasthenic Syndrome | Limb-Girdle Muscular Dystrophy | Congenital Muscular Dystrophy With ITGA7 (Integrin Alpha-7) Deficiency | Alpha-Dystroglycanopathy (Congenital Muscular Dystrophy and Abnormal Glycosylation of Dystroglycan With Severe Epilepsy) and other conditionsUnited States
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-
Consorci Sanitari de l'AnoiaParc de Salut Mar; Germans Trias i Pujol HospitalCompleted
-
Ottawa Hospital Research InstituteRecruiting
-
Washington University School of MedicineZimmer BiometTerminated
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Encore Medical, L.P.CompletedRotator Cuff Arthropathy | Failed Total Shoulder | Failed Hemi-arthroplastyUnited States
-
DePuy OrthopaedicsNot yet recruiting
-
I.M. Sechenov First Moscow State Medical UniversityUnknownShoulder Osteoarthritis | Proximal Humeral Fracture | Avascular Necrosis of HumerusRussian Federation
-
Hospital Universitario Reina Sofia de CordobaRecruiting
-
Central Hospital, Nancy, FranceEnrolling by invitation
-
Hospital del MarCompletedRotator Cuff Arthropathy | Outcomes Assessments, Patients