Reverse Shoulder Replacement: Age 60 or Younger Outcomes

NCT03148184 | Completed

• 1 other identifier: 201408124
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the early outcomes following Reverse Shoulder Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these patients, evaluating their clinical outcomes and radiographic appearance.The investigators would like to know how quickly they are healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a better defined and study supported understanding of the post-operative recovery timeline in the younger population.

Conditions

Shoulder Arthritis

Keywords

reverse total shoulder arthroplasty; 60 years old or younger; outcomes

Outcome Measures

Primary Outcomes (1)

• Assess functional change from before surgery to two years post surgery

  Assess changes in range of motion as part of the overall clinical outcome function scores. ASES (American Shoulder and Elbow Questionnaire)

  2 years post op

Secondary Outcomes (1)

• Radiographic Outcomes

  2 years post op

Interventions

shoulder x-ray DIAGNOSTIC_TEST

post operative shoulder x-ray at minimum 2 year post op

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 60 or younger who are will undergo or have undergone a primary reverse shoulder arthroplasty with a single implant system by one of our four surgeons.

You may qualify if:

• years old or younger at the time of surgery
• reverse shoulder arthroplasty with a single implant system by one of our four surgeons

You may not qualify if:

• minors
• unable to complete imaging portion of the two-year follow-up due to health safety/exposure concerns
• unwilling/unable to return for follow up
• Revision procedure

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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.

  PMID: 16951091 BACKGROUND

• 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.

  PMID: 21196544 BACKGROUND

• 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.

  PMID: 21116759 BACKGROUND

Study Officials

• Aaron Chamberlain, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: May 10, 2017
• Study Start: November 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)