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Reverse Total Shoulder Arthroplasty: Comparative Study of New Technologies

Current Research
Reverse Total Shoulder Arthroplasty: Comparative Study of New Technologies

Background

There has been high intersurgeon and intrasurgeon variability with RSA preoperative planning

Reverse total shoulder arthroplasty (RSA) has shown excellent clinical success for the treatment of rotator cuff deficiency, primary glenohumeral osteoarthritis, and inflammatory glenohumeral arthritis.1-4 The success of the procedure is dependent on patient selection, identification of preoperative glenoid morphology, implant selection and position, surgical technique, and postoperative rehabilitation.

Glenoid malposition can lead to baseplate loosening, scapular notching, impingement, and poor outcomes.5-8 Standard preoperative planning using two-dimensional (2D) imaging and manufacturer instrumentation (sRSA) has been shown to be imprecise for severe glenoid deformity.9 Preoperative planning utilizing three-dimensional (3D) imaging with patient specific instrumentation (pRSA) or computer navigation (cRSA) has been shown to improve glenoid implantation accuracy.10-26

Kircher et al. performed a prospective, randomised clinical study that compared primary total shoulder arthroplasty for osteoarthritis with or without intraoperative navigation.21 They found improved accuracy in glenoid retroversion using intraoperative navigation. Hendel et al. compared the use of patient specific instrumentation and the use of instruments provided by the implant manufacturer for primary total shoulder arthroplasty for osteoarthritis.15 They found that 3D preoperative planning with patient specific instrumentation resulted in more accurate placement of the glenoid component. The current literature on preoperative 3D imaging with patient specific instrumentation or computer navigation for RSA has focused on the accuracy of glenoid implant positioning.10,11,13,26 There have been no studies comparing the range of motion, pain, functional outcomes, patient satisfaction, or complications between sRSA, pRSA, or cRSA.

There has been high intersurgeon and intrasurgeon variability with RSA preoperative planning.27 There are no established preoperative planning parameters for glenoid implant position, nor guidelines for use of sRSA, pRSA, or cRSA based on glenoid morphology or clinical outcomes.

Objectives

PRIMARY OBJECTIVES:

  • To compare shoulder range of motion between standard two-dimensional preoperative planning and manufacturer instrumentation for reverse total shoulder arthroplasty (sRSA) and using preoperative three-dimensional surgical simulation with patient-specific instrumentation (pRSA) or computer navigation (cRSA).
  • To compare pain, functional outcomes, and patient satisfaction between sRSA, pRSA, and cRSA.
  • To compare accuracy of glenoid and humeral implant position between sRSA, pRSA, and cRSA.
  • To compare complications and reoperations between sRSA, pRSA, and cRSA

SECONDARY OBJECTIVES:

  • To establish preoperative planning parameters for implant position based on preoperative glenoid morphology and clinical outcomes
  • To establish indications for the use of sRSA, pRSA, and cRSA

Design

This will be a two-stage study as follows:
Stage 1: Prospective non-randomised controlled study
Stage 2: Prospective single-blinded randomized controlled study

Study Procedure

All consecutive patients indicated for elective reverse total shoulder arthroplasty will be considered eligible. After reading the information sheet and signing the consent form, they will be enrolled. Baseline characteristics of age, sex, hand dominance, medications, body mass index, prior surgeries, alcohol/tobacco use, and relevant comorbidities will be recorded in a deidentified Patient Data Form (PDF) along with arthritis type, associated arthritis characteristics based on pre-operative X-rays and CT scan, pre-operative range of motion, Constant Score, and scores from 2 x Patient Reported Outcome Measures (PROMs): the American Shoulder and Elbow Society Score – Patient and the Pain and Normal Visual Analog Score.

Stage 1

In stage 1 of the study, the first 40 patients enrolled in the study will undergo reverse total shoulder arthroplasty with two-dimensional (2D) preoperative planning (radiographs and CT scan) and using standard manufacturer instrumentation (sRSA) with the Zimmer Biomet Comprehensive Reverse Total Shoulder Arthroplasty system (Biomet Orthopaedics, Warsaw, Indiana, USA). This is how the principal investigator performs his surgeries currently. The next 40 patients enrolled in the study will undergo reverse total shoulder arthroplasty with three-dimensional (3D) preoperative planning (X-rays, CT scans, and 3D reconstruction) and using patient specific instrumentation (pRSA) with the Zimmer PSI Shoulder system and Signature ONE planning software. The next 40 patients enrolled in the study will undergo reverse total shoulder arthroplasty with 3D preoperative planning (X-rays, CT scans, and 3D reconstruction) and using intraoperative computer navigation (cRSA) with the Zimmer Biomet Comprehensive Reverse Total Shoulder Arthroplasty system and Signature ONE planning software.

The surgery will proceed with the surgeon performing sRSA, pRSA, or cRSA for the patient’s shoulder arthritis depending on the patient’s predetermined enrolment. The rotator cuff status, implant size, use of augmentation or bone graft, and operative time will be documented. After the surgery, the patient will be admitted to the hospital for routine postoperative care. A postoperative CT scan of the shoulder will be obtained to measure implant position and accuracy of the preoperative planning and instrumentation used for implantation. The patient will be discharged from the hospital depending on pain control and medical status. They will follow-up in clinic at 2 weeks, 4 months, 1 year, and 2 years from surgery.
The primary outcome will be range of motion. Secondary outcomes will be scores on the Constant Score, the American Shoulder and Elbow Society Score – Patient, the Pain and Normal Visual Analog Score and the Patient Satisfaction Post Op Score as well as implant position, and any complications.

All outcomes will be documented on the PDF. Postoperative shoulder X-rays will be obtained at each clinic visit to evaluate for implant position, fracture, dislocation, scapular notching, or implant loosening. All data will be collated and analysed.
As not all technologies are immediately available in 2021, the decision was made to do a non-randomised study first (Stage 1). The cRSA will be available in Australia in early 2022. Therefore, stage 1 will allow patients to be enrolled in the sRSA and pRSA groups. Then a randomised study (Stage 2) will be performed once all techniques are available and the surgeon and staff are equally experienced in their use. Also, the randomised trial can correct for any timeline bias in the first study (Stage 1). If there is no significant bias (change in patient characteristics, non-randomisation process, or increasing surgical experience with the technique) in Stage 1, some outcomes may be combined from Stage 1 and Stage 2 for additional statistical analyses.

Stage 2

In stage 2 of the study, all consecutive patients indicated for elective reverse total shoulder arthroplasty will be considered eligible. After reading the information sheet and signing the consent form, they will be randomised to one of 3 study groups: sRSA, pRSA, or cRSA. Patients will be randomly assigned to groups by the use of sealed and numbered envelopes opened at the time their surgery is booked. Inside their envelopes are instructions for which group patients will be assigned.
Randomisation will be done using computer software to generate the numbers for the envelopes. This will be a single-blinded study. The patient will be blinded to the type of technology used for their RSA. The surgeon will not be blinded to which groups patients are assigned because he needs this information in order to perform the surgery with the indicated instrumentation. The pre-operative data collection, surgery, and post-operative data collection will be performed in the same was as in Stage 1.

Inclusion Criteria

  • Patients diagnosed with rotator cuff deficient glenohumeral osteoarthritis, glenohumeral osteoarthritis with intact rotator cuff, or inflammatory glenohumeral arthritis
  • Patients consented for reverse total shoulder arthroplasty
  • Patients capable of giving informed consent to participate in the study

Exclusion Criteria

  • Patients with reverse total shoulder arthroplasty for an acute proximal humerus fracture
  • Patients with reverse total shoulder arthroplasty for pathologic aetiology
  • Patients with axillary nerve palsy or non-functioning deltoid muscle
  • Patients with revision total shoulder arthroplasty to reverse total shoulder arthroplasty
  • Patients with history of infection in the affected shoulder
  • Patients who are unable to have a CT scan

Ethics and Governance

Approved by St Vincent’s Hospital Human Research Ethics Committee. HREC reference  2021/ETH11591.

Status

Recruiting.

References

  • McFarland EG, Huri G, Hyun YS, Petersen SA, Srikumaran U. Reverse total shoulder arthroplasty without bone-grafting for severe glenoid bone loss in patients with osteoarthritis and intact rotator cuff. J Bone Joint Surg Am. 2016;98(21):1801-1807.
  • Mizuno N, Denard PJ, Raiss P, Walch G. Reverse total shoulder arthroplasty for primary glenohumeral osteoarthritis in patients with a biconcave glenoid. J Bone Joint Surg Am. 2013;95(14):1297-1304
  • Hattrup SJ, Sanchez-Sotelo J, Sperling JW, Cofield RH. Reverse shoulder replacement for patients with inflammatory arthritis. J Hand Surg Am. 2012;37(9):1888-1894.
  • Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008;90(6):1244-1251.
  • Lévigne C, Garret J, Boileau P, Alami G, Favard L, Walch G. Scapular notching in reverse shoulder arthroplasty: is it important to avoid it and how? Clin Orthop Relat Res. 2011;469(9):2512-2520.
  • Simovitch RW, Zumstein MA, Lohri E, Helmy N, Gerber C. Predictors of scapular notching in patients managed with the Delta III reverse total shoulder replacement. J Bone Joint Surg Am. 2007;89(3):588-600.
  • Gutiérrez S, Greiwe RM, Frankle MA, Siegal S, Lee WE. Biomechanical comparison of component position and hardware failure in the reverse shoulder prosthesis. J Shoulder Elbow Surg. 2007;16(3 Suppl):S9-S12.
  • Gutiérrez S, Walker M, Willis M, Pupello DR, Frankle MA. Effects of tilt and glenosphere eccentricity on baseplate/bone interface forces in a computational model, validated by a mechanical model, of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2011;20(5):732-739.
  • Iannotti JP, Greeson C, Downing D, Sabesan V, Bryan JA. Effect of glenoid deformity on glenoid component placement in primary shoulder arthroplasty. J Shoulder Elbow Surg. 2012;21(1):48-55.
  • Berhouet J, Gulotta LV, Dines DM, et al. Preoperative planning for accurate glenoid component positioning in reverse shoulder arthroplasty. Orthop Traumatol Surg Res. 2017;103(3):407-413.
  • Verborgt O, De Smedt T, Vanhees M, Clockaerts S, Parizel PM, Van Glabbeek F. Accuracy of placement of the glenoid component in reversed shoulder arthroplasty with and without navigation. J Shoulder Elbow Surg. 2011;20(1):21-26
  • Trouilloud P, Gonzalvez M, Martz P, et al. Duocentric® reversed shoulder prosthesis and Personal Fit® templates: innovative strategies to optimize prosthesis positioning and prevent scapular notching. Eur J Orthop Surg Traumatol. 2014;24(4):483-495.
  • Levy JC, Everding NG, Frankle MA, Keppler LJ. Accuracy of patient-specific guided glenoid baseplate positioning for reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2014;23(10):1563-1567.
  • Iannotti JP, Walker K, Rodriguez E, Patterson TE, Jun B-J, Ricchetti ET. Accuracy of 3-dimensional planning, implant templating, and patient-specific instrumentation in anatomic total shoulder arthroplasty. J Bone Joint Surg Am. 2019;101(5):446-457.
  • Hendel MD, Bryan JA, Barsoum WK, et al. Comparison of patient-specific instruments with standard surgical instruments in determining glenoid component position: a randomised prospective clinical trial. J Bone Joint Surg Am. 2012;94(23):2167-2175.
  • Raiss P, Walch G, Wittmann T, Athwal GS. Is preoperative planning effective for intraoperative glenoid implant size and type selection during anatomic and reverse shoulder arthroplasty? J Shoulder Elbow Surg. 2020;29(10):2123-2127.
  • Boileau P, Cheval D, Gauci M-O, Holzer N, Chaoui J, Walch G. Automated three-dimensional measurement of glenoid version and inclination in arthritic shoulders. J Bone Joint Surg Am. 2018;100(1):57-65.
  • Schoch BS, Haupt E, Leonor T, Farmer KW, Wright TW, King JJ. Computer navigation leads to more accurate glenoid targeting during total shoulder arthroplasty compared with 3-dimensional preoperative planning alone. J Shoulder Elbow Surg. 2020;29(11):2257-2263.
  • Nashikkar PS, Scholes CJ, Haber MD. Computer navigation re-creates planned glenoid placement and reduces correction variability in total shoulder arthroplasty: an in vivo case-control study. J Shoulder Elbow Surg. 2019;28(12):e398-e409.
  • Iannotti JP, Weiner S, Rodriguez E, et al. Three-dimensional imaging and templating improve glenoid implant positioning. J Bone Joint Surg Am. 2015;97(8):651-658.
  • Kircher J, Wiedemann M, Magosch P, Lichtenberg S, Habermeyer P. Improved accuracy of glenoid positioning in total shoulder arthroplasty with intraoperative navigation: a prospective-randomised clinical study. J Shoulder Elbow Surg. 2009;18(4):515-520.
  • Nguyen D, Ferreira LM, Brownhill JR, et al. Improved accuracy of computer assisted glenoid implantation in total shoulder arthroplasty: an in-vitro randomised controlled trial. J Shoulder Elbow Surg. 2009;18(6):907-914.
  • Throckmorton TW, Gulotta LV, Bonnarens FO, et al. Patient-specific targeting guides compared with traditional instrumentation for glenoid component placement in shoulder arthroplasty: a multi-surgeon study in 70 arthritic cadaver specimens. J Shoulder Elbow Surg. 2015;24(6):965-971.
  • Jacquot A, Gauci M-O, Chaoui J, et al. Proper benefit of a three dimensional pre-operative planning software for glenoid component positioning in total shoulder arthroplasty. Int Orthop. 2018;42(12):2897-2906.
  • Werner BS, Hudek R, Burkhart KJ, Gohlke F. The influence of three-dimensional planning on decision-making in total shoulder arthroplasty. J Shoulder Elbow Surg. 2017;26(8):1477-1483.
  • Cabarcas BC, Cvetanovich GL, Gowd AK, Liu JN, Manderle BJ, Verma NN. Accuracy of patient-specific instrumentation in shoulder arthroplasty: a systematic review and meta-analysis. JSES Open Access. 2019;3(3):117-129.
  • Parsons M, Greene A, Polakovic S, et al. Assessment of surgeon variability in preoperative planning of reverse total shoulder arthroplasty: a quantitative comparison of 49 cases planned by 9 surgeons. J Shoulder Elbow Surg. 2020;29(10):2080-2088
  • Bacle G, Nové-Josserand L, Garaud P, Walch G. Long-term outcomes of reverse total shoulder arthroplasty: a follow-up of a previous study. J Bone Joint Surg Am. 2017;99(6):454-461.
  • National Statement on Ethical Conduct in Human Research (2007) – Updated December 2013 (The National Statement), Commonwealth of Australia, Canberra.
  • Nashikkar PS, Scholes CJ, Haber MD. Computer navigation re-creates planned glenoid placement and reduces correction variability in total shoulder arthroplasty: an in vivo case-control study. J Shoulder Elbow Surg. 2019;28(12):e398-e409.

sydney-shoulder-research-institute-projects

Lead Investigator:

Dr Ben Cass

Commenced:

2021

Category:

Current Projects

In Research - Current

Reverse Total Shoulder Arthroplasty: Comparative Study of New Technologies

In Research - Current

Muscle advancement in massive rotator cuff repair