Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02966886

TSA Techniques in Glenohumeral OA

Led by Ottawa Hospital Research Institute · Updated on 2024-04-30

216

Participants Needed

1

Research Sites

605 weeks

Total Duration

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AI-Summary

What this Trial Is About

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.

CONDITIONS

Official Title

TSA Techniques in Glenohumeral OA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both men and women with advanced osteoarthritis of the shoulder joint
  • Considered candidates for shoulder replacement by their surgeon
  • Failed at least 6 months of standard non-surgical management including medication, physiotherapy, and activity modification
  • Glenoid retroversion between 10 and 26 degrees
  • Imaging and surgery confirm advanced cartilage loss of the humeral head
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Glenoid retroversion less than 10 degrees or greater than 27 degrees
  • Active joint or systemic infection
  • Rotator cuff arthropathy
  • Significant muscle paralysis
  • Charcot's arthropathy
  • Major medical illness with life expectancy under 1 year or high surgical risk
  • Unable to understand the consent process
  • Pregnancy
  • Psychiatric illness preventing informed consent
  • Unwillingness to be followed for the study duration
  • Glenoid retroversion cannot be corrected to within 10 degrees of neutral surgically
  • Previous shoulder surgery on the affected side
  • Rheumatoid arthritis in the affected shoulder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H8L6

Actively Recruiting

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Research Team

P

Peter Lapner, MD

CONTACT

K

Katie McIlquham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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