Clinical trial NCT03151109: Glenoid Bone Grafting for RTSA: Clinical & Radiographic Outcomes
Official title: Glenoid Bone Grafting for Reverse Shoulder Arthroplasty: Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteo Arthritis Shoulders
Keywords: reverse total shoulder arthroplasty
glenoid bone loss
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2017-05-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with substantial glenoid bone loss in the context of severe glenohumeral arthrosis, advanced cuff tear arthropathy or those who have undergone prior shoulder arthroplasty and have or will undergo a reverse shoulder replacement with structural bone graft to address the problem.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radiographic Outcome
timeFrame: minimum 1 year post op
Secondary outcomes:
measure: Functional outcomes at year one
timeFrame: collected at 1 year post surgery
measure: Functional outcomes at year two
timeFrame: collected 2 years post surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Aaron Chamberlain, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2106/JBJS.F.00123.
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.
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.
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.
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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.
citation: 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. doi: 10.1067/mse.2001.113961.
citation: Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Mole 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. doi: 10.1302/0301-620x.86b3.14024.