EPBG: Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03151109
• Collaborator: Zimmer Biomet (Industry)
• Enrollment: 67
• Location: 1
• Actual Duration (Months): 57
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study will look at patient radiographic and functional outcomes who have or will undergo a reverse, extended peg, shoulder arthroplasty (replacement) that requires the use of glenoid bone grafting.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Shoulders	Diagnostic Test: CT Scan

Detailed Description

Glenoid bone loss is a known issue with reverse shoulder implants and can lead to issues with implant fixation and stability over time. To address this issue an extended peg glenoid baseplate is used and area around plate is augmented with bone (auto or allo)graft material to encourage bony callous growth around the implant. This study is to look at this area of concern and determine if glenoid bone loss is occurring in the patients where these measures have been taken to deter its development.

Study Design

• Study Type: Observational
• Actual Enrollment: 67 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Glenoid Bone Grafting for Reverse Shoulder Arthroplasty: Clinical and Radiographic Outcomes
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Outcome Measures

Primary Outcome Measures

1. Radiographic Outcome [minimum 1 year post op]

   Evaluate Bone Graft Incorporation - review images to determine signs of humeral or glenoid radiolucency, radiographic loosening, fracture, notching, and graft incorporation versus resorption on CT and/or XRay images.

Secondary Outcome Measures

1. Functional outcomes at year one [collected at 1 year post surgery]

   Evaluate postoperative clinical outcome scores

2. Functional outcomes at year two [collected 2 years post surgery]

   Evaluate postoperative clinical outcome scores

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult patients who have undergone a reverse shoulder arthroplasty with the an extended peg baseplate and structural bone graft (autograft humeral head or allograft femoral head).

2. Adult patients who are indicated for a long-pegged baseplate and glenoid bone grafting (autograft humeral head or allograft femoral head) as part of their reverse shoulder arthroplasty in our clinic,

3. bone graft is truly structural involving at least 50% of the glenoid baseplate

4. may be a primary or a revision surgery

Exclusion Criteria:

1. patients with missing baseline (preop) data,

2. patients who are unwilling to participate in a final follow-up evaluation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Zimmer Biomet

Investigators

• Principal Investigator: Aaron Chamberlain, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001 May-Jun;10(3):217-24.
• Frankle M, Levy JC, Pupello D, Siegal S, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178-90.
• Hamada K, Fukuda H, Mikasa M, Kobayashi Y. Roentgenographic findings in massive rotator cuff tears. A long-term observation. Clin Orthop Relat Res. 1990 May;(254):92-6.
• 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.
• Naveed MA, Kitson J, Bunker TD. The Delta III reverse shoulder replacement for cuff tear arthropathy: a single-centre study of 50 consecutive procedures. J Bone Joint Surg Br. 2011 Jan;93(1):57-61. doi: 10.1302/0301-620X.93B1.24218.
• Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop Relat Res. 2011 Sep;469(9):2476-82. doi: 10.1007/s11999-010-1683-z.
• Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
• Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé 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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03151109
• Other Study ID Numbers: 201507050
• First Posted: May 12, 2017
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Washington University School of Medicine: reverse total shoulder arthroplasty; glenoid bone loss
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Feb 3, 2022