Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes

Osteo Arthritis Shoulders Clinical Trial

— EPBG  

Official title:

Glenoid Bone Grafting for Reverse Shoulder Arthroplasty: Clinical and Radiographic Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151109
• Other study ID #: 201507050
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: June 2021

Study information

• Verified date: February 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis

Intervention

Diagnostic Test:
• CT Scan
CT scan at minimum 1 year post op

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Outcome	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.	minimum 1 year post op
Secondary	Functional outcomes at year one	Evaluate postoperative clinical outcome scores	collected at 1 year post surgery
Secondary	Functional outcomes at year two	Evaluate postoperative clinical outcome scores	collected 2 years post surgery