Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis

NCT04105478 | Unknown

• 1 other identifier: Nano study
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Glenohumeral Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

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

• Plain radiographs

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

• Oxford Shoulder Score (OSS)

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

• Constant-Murley score

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

• Pain and patient-satisfaction: visual analogue scale (VAS)

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

Study Arms (2)

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

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.

Procedure: Shoulder arthroplasty

Interventions

Shoulder arthroplasty PROCEDURE

Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty

Un-cemented Comprehensive Nano stemless shoulder arthroplasty; Un-cemented Comprehensive stemmed total shoulder arthroplasty

Eligibility Criteria

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

You may qualify if:

• All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Gentofte

You may not qualify if:

• below 18 years of age
• cognitive or linguistic impairment
• insufficient function of the rotator cuff
• poor bone quality
• ASA group 4-5

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

Related Publications (52)

• 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

• Ban 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.

  PMID: 23651718 BACKGROUND

• Barvencik 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.

  PMID: 19630001 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

• Brolin 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.

  PMID: 28763354 BACKGROUND

• Bryant 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.

  PMID: 16140808 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

• 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

• Gartsman 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.

  PMID: 10653081 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

• Izquierdo 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.

  PMID: 20511443 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

• Johnston PS, Creighton RA, Romeo AA. Humeral component revision arthroplasty: outcomes of a split osteotomy technique. J Shoulder Elbow Surg. 2012 Apr;21(4):502-6. doi: 10.1016/j.jse.2011.02.001. Epub 2011 May 19.

  PMID: 21600792 BACKGROUND

• Kumar S, Sperling JW, Haidukewych GH, Cofield RH. Periprosthetic humeral fractures after shoulder arthroplasty. J Bone Joint Surg Am. 2004 Apr;86(4):680-9. doi: 10.2106/00004623-200404000-00003.

  PMID: 15069130 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

• Liew AS, Johnson JA, Patterson SD, King GJ, Chess DG. Effect of screw placement on fixation in the humeral head. J Shoulder Elbow Surg. 2000 Sep-Oct;9(5):423-6. doi: 10.1067/mse.2000.107089.

  PMID: 11075327 BACKGROUND

• Lo IK, Litchfield RB, Griffin S, Faber K, Patterson SD, Kirkley A. Quality-of-life outcome following hemiarthroplasty or total shoulder arthroplasty in patients with osteoarthritis. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Oct;87(10):2178-85. doi: 10.2106/JBJS.D.02198.

  PMID: 16203880 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

• Maloney WJ, Sychterz C, Bragdon C, McGovern T, Jasty M, Engh CA, Harris WH. The Otto Aufranc Award. Skeletal response to well fixed femoral components inserted with and without cement. Clin Orthop Relat Res. 1996 Dec;(333):15-26.

  PMID: 8981879 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

• 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

• Phipatanakul WP, Bowen JM, Jobe CM. Removal of well-fixed flanged humeral prostheses may require humeral expansion. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):724-7. doi: 10.1016/j.jse.2008.11.021. Epub 2009 Mar 21.

  PMID: 19318282 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

• 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

• Sahota S, Sperling JW, Cofield RH. Humeral windows and longitudinal splits for component removal in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Oct;23(10):1485-91. doi: 10.1016/j.jse.2014.02.004. Epub 2014 Apr 22.

  PMID: 24766791 BACKGROUND

• Singh JA, Sperling J, Buchbinder R, McMaken K. Surgery for shoulder osteoarthritis: a Cochrane systematic review. J Rheumatol. 2011 Apr;38(4):598-605. doi: 10.3899/jrheum.101008. Epub 2011 Jan 15.

  PMID: 21239751 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

• Van Thiel GS, Halloran JP, Twigg S, Romeo AA, Nicholson GP. The vertical humeral osteotomy for stem removal in revision shoulder arthroplasty: results and technique. J Shoulder Elbow Surg. 2011 Dec;20(8):1248-54. doi: 10.1016/j.jse.2010.12.013. Epub 2011 Mar 21.

  PMID: 21420326 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

• Nyring MRK, Olsen BS, Yilmaz M, Petersen MM, Flivik G, Rasmussen JV. Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis-study protocol for a randomized controlled trial. Trials. 2020 Oct 7;21(1):830. doi: 10.1186/s13063-020-04763-8.

  PMID: 33028390 DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Marc Randall Kristensen Nyring

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Randall Kristensen Nyring

CONTACT

+45 51889121; marc.randall.kristensen.nyring@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, PhD student

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. 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 26, 2019
• Study Start: March 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2025
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)