Clinical trial NCT03148184: Reverse Shoulder Replacement: Age 60 or Younger Outcomes
Official title: Reverse Shoulder Arthroplasty in Patients 60 Years Old and Younger: Short-term Clinical and Radiographic Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Arthritis
Keywords: reverse total shoulder arthroplasty
60 years old or younger
outcomes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2017-05-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: This study is looking at patients who are sixty years or younger at the time of they undergo a reverse total shoulder replacement. This is an important population to look at their functional and clinical outcomes as they are often still employed and have more physical demands upon their shoulder in everyday life than the older replacement population for which there are more outcome data available. The investigators would like to determine how the younger population is 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 study supported understanding of the post-operative recovery timeline in the younger population. The investigators will review x-rays to evaluate healing at two years. Functional surveys are given pre and post operatively (1 \& 2 years) and these will be reviewed as well. A physical exam is also performed to determine range of motion pre and post operatively (1 \& 2 years).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assess functional change from before surgery to two years post surgery
timeFrame: 2 years post op
Secondary outcomes:
measure: Radiographic Outcomes
timeFrame: 2 years post op
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.