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

NCT05447819 | Recruiting

• 1 other identifier: H-21042181
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 ]

  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 ]

  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 ]

  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 ]

  Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively

• Side effects and complications [ Time Frame: 2 years postoperatively ]

  2 years postoperatively

Study Arms (2)

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

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

Procedure: Reverse shoulder arthroplsaty

Interventions

Reverse shoulder arthroplsaty PROCEDURE

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

DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension; Standard DELTA Xtend Reverse Shoulder System

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• DePuy Synthes: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Hellerup, Denmark, 2900, Denmark

RECRUITING

Related Publications (43)

• 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.

  PMID: 28410836 BACKGROUND

• 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.

  PMID: 27649258 BACKGROUND

• 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.

  PMID: 28918227 BACKGROUND

• 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.

  PMID: 22383318 BACKGROUND

• 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.

  PMID: 18218327 BACKGROUND

• 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.

  PMID: 8682827 BACKGROUND

• 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.

  PMID: 24007651 BACKGROUND

• Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.

  PMID: 22047932 BACKGROUND

• 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.

  PMID: 30260909 BACKGROUND

• 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.

  PMID: 2294552 BACKGROUND

• 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.

  PMID: 8263569 BACKGROUND

• 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.

  PMID: 22036546 BACKGROUND

• 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.

  PMID: 22795879 BACKGROUND

• 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.

  PMID: 22733440 BACKGROUND

• 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.

  PMID: 16826090 BACKGROUND

• 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.

  PMID: 23126576 BACKGROUND

• 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.

  PMID: 16761153 BACKGROUND

• 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.

  PMID: 27583112 BACKGROUND

• 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.

  PMID: 11795997 BACKGROUND

• 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.

  PMID: 8981273 BACKGROUND

• 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.

  PMID: 3076046 BACKGROUND

• 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.

  PMID: 25220196 BACKGROUND

• 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.

  PMID: 28111179 BACKGROUND

• 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.

  PMID: 22262426 BACKGROUND

• 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.

  PMID: 22047783 BACKGROUND

• 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.

  PMID: 25086124 BACKGROUND

• 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.

  PMID: 17493557 BACKGROUND

• 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.

  PMID: 24133377 BACKGROUND

• 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.

  PMID: 25159010 BACKGROUND

• 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.

  PMID: 29474992 BACKGROUND

• 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.

  PMID: 27707849 BACKGROUND

• 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.

  PMID: 24650020 BACKGROUND

• 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.

  PMID: 24692621 BACKGROUND

• 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.

  PMID: 23333170 BACKGROUND

• 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.

  PMID: 7744919 BACKGROUND

• 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.

  PMID: 15125127 BACKGROUND

• 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.

  PMID: 22773108 BACKGROUND

• 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.

  PMID: 28464752 BACKGROUND

• 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.

  PMID: 18635360 BACKGROUND

• Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.

  PMID: 16195075 BACKGROUND

• Valstar E, Kaptein B, Nelissen R. Radiostereometry and new prostheses. Acta Orthop. 2012 Apr;83(2):103-4. doi: 10.3109/17453674.2012.678796. Epub 2012 Apr 11. No abstract available.

  PMID: 22489889 BACKGROUND

• Winther NS, Jensen CL, Jensen CM, Lind T, Schroder HM, Flivik G, Petersen MM. Comparison of a novel porous titanium construct (Regenerex(R)) to a well proven porous coated tibial surface in cementless total knee arthroplasty - A prospective randomized RSA study with two-year follow-up. Knee. 2016 Dec;23(6):1002-1011. doi: 10.1016/j.knee.2016.09.010. Epub 2016 Oct 19.

  PMID: 27769563 BACKGROUND

• Winther N, Jensen C, Petersen M, Lind T, Schroder H, Petersen M. Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study. Int Orthop. 2016 Feb;40(2):285-94. doi: 10.1007/s00264-015-2852-1. Epub 2015 Jul 17.

  PMID: 26183139 BACKGROUND

Central Study Contacts

Marie Louise Jensen, MD

CONTACT

+4525717963; marie.louise.jensen.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind the observer when implant migration is evaluated using RSA. The patient-reported outcomes are solely evaluated by the patients before the follow-up examination without involving surgeons or observer Blinding of the patients: The patients will be blinded to their allocated treatment the first two years after surgery. Blinding of Statistician: The randomization is blinded to the statistician who perform the analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 7, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

DK (1)