Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

NCT05395819 | Recruiting

• 1 other identifier: Pro00090427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)". Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)

  WOOS is a valid, reliable and responsive 19-item self-administered questionnaire that assesses health-related quality of life in patients with osteoathritis undergoing arthroplasty. It consists of 4 domains: pain and physical symptoms; sports, recreation, and work; lifestyle function; and emotional function. The score ranges from 0 to 1,900, with a higher raw score corresponding with the worse outcome.

  Baseline, 6 weeks, 3-, 6- and 12-months

Secondary Outcomes (10)

• Number of re-operations

  6 weeks, 3-, 6- and 12-months

• Change in Shoulder Range of Motion (ROM)

  Baseline, 6 weeks, 3-, 6- and 12-months

• Change in Shoulder Pain

  Baseline, 6 weeks, 3-, 6- and 12-months

• Change in Shoulder Strength

  Baseline, 6- and 12-months

• Change in The American Shoulder and Elbow Surgeon's (ASES) questionnaire

  Baseline, 6 weeks, 3-, 6- and 12-months

Study Arms (2)

Reverse Total Shoulder Arthroplasty (RTSA)

EXPERIMENTAL

Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.

Procedure: Reverse Total Shoulder Arthroplasty (RTSA)

Total Shoulder Arthroplasty (TSA)

ACTIVE COMPARATOR

Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.

Procedure: Total Shoulder Arthroplasty (TSA)

Interventions

Reverse Total Shoulder Arthroplasty (RTSA) PROCEDURE

Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.

Reverse Total Shoulder Arthroplasty (RTSA)

Total Shoulder Arthroplasty (TSA) PROCEDURE

Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.

Also known as: Anatomical

Total Shoulder Arthroplasty (TSA)

Eligibility Criteria

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

You may qualify if:

• Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
• The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
• Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
• Activity modification
• Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss
• Patients may present with a glenoid deficiency and \>15 degrees of retroversion
• years of age and older

You may not qualify if:

• Active joint or systemic infection
• Rotator cuff arthropathy
• Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
• Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
• Significant muscle paralysis
• Charcot's arthropathy
• Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
• Active Workers Compensation Board (WCB) claim
• Unable to understand the consent form/process
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for the duration of the study
• History of previous shoulder surgery on affected side

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator
• Canadian Orthopaedic Foundation: collaborator

Study Sites (8)

Royal Alexandra Hospital (Orthopaedic Surgical Centre)

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

Glen Sather Sports Medicine Clinic (University of Alberta)

Edmonton, Alberta, T6G 1Z1, Canada

RECRUITING

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 1Z1, Canada

RECRUITING

Collaborative Orthopaedic Research (CORe), Clinical Sciences Building

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

RECRUITING

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (11)

• Ingram M, Symmons DPM. The burden of musculoskeletal conditions. Medicine. 2018; 46(3):152-155. https://doi.org/10.1016/j.mpmed.2017.12.005

  BACKGROUND

• Eichinger JK, Galvin JW. Management of complications after total shoulder arthroplasty. Curr Rev Musculoskelet Med. 2015 Mar;8(1):83-91. doi: 10.1007/s12178-014-9251-x.

  PMID: 25672497 BACKGROUND

• Fink B, Strauss JM, Lamla U, Kurz T, Guderian H, Ruther W. [Endoprosthetic surface replacement of the head of the humerus]. Orthopade. 2001 Jun;30(6):379-85. doi: 10.1007/s001320170087. German.

  PMID: 11480090 BACKGROUND

• Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.

  PMID: 22258770 BACKGROUND

• Pandya J, Johnson T, Low AK. Shoulder replacement for osteoarthritis: A review of surgical management. Maturitas. 2018 Feb;108:71-76. doi: 10.1016/j.maturitas.2017.11.013. Epub 2017 Nov 21.

  PMID: 29290218 BACKGROUND

• Vogt MT, Simonsick EM, Harris TB, Nevitt MC, Kang JD, Rubin SM, Kritchevsky SB, Newman AB; Health, Aging and Body Composition Study. Neck and shoulder pain in 70- to 79-year-old men and women: findings from the Health, Aging and Body Composition Study. Spine J. 2003 Nov-Dec;3(6):435-41. doi: 10.1016/s1529-9430(03)00150-5.

  PMID: 14609687 BACKGROUND

• Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002 Mar-Apr;11(2):130-5. doi: 10.1067/mse.2002.121146.

  PMID: 11988723 BACKGROUND

• Wirth MA, Rockwood CA Jr. Complications of shoulder arthroplasty. Clin Orthop Relat Res. 1994 Oct;(307):47-69.

  PMID: 7924048 BACKGROUND

• Stephens SP, Paisley KC, Jeng J, Dutta AK, Wirth MA. Shoulder arthroplasty in the presence of posterior glenoid bone loss. J Bone Joint Surg Am. 2015 Feb 4;97(3):251-9. doi: 10.2106/JBJS.N.00566.

  PMID: 25653326 BACKGROUND

• Walch G, Young AA, Boileau P, Loew M, Gazielly D, Mole D. Patterns of loosening of polyethylene keeled glenoid components after shoulder arthroplasty for primary osteoarthritis: results of a multicenter study with more than five years of follow-up. J Bone Joint Surg Am. 2012 Jan 18;94(2):145-50. doi: 10.2106/JBJS.J.00699.

  PMID: 22258001 BACKGROUND

• Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.

  PMID: 10512449 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder; Models, Anatomic

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Models, Structural; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Central Study Contacts

Ailar Ramadi, PhD

CONTACT

780-492-2398; Ailar.Ramadi@albertahealthservices.ca

Lauren Beaupre, PhD

CONTACT

780-492-8626; lauren.beaupre@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. The surgeons will use a Research Electronic Data Capture (REDCap) software to randomize the participant. REDCap is password protected and only accessibly for research personnel. The outcome assessors will not have access to the randomization information in REDCap which will maintain blinding to participant group allocation. Surgeons will not informe participant about procedure received until the end of last follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 27, 2022
• Study Start: May 30, 2022
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)