Recruiting

TSA Techniques

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02966886

Conditions

Osteoarthritis, Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eccentric Reaming

Augmented Glenoid Component Implantation

Posterior Glenoid Bone Grafting

Study Details

Brief summary:

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

Osteoarthritis, Shoulder

Study ID

NCT02966886

Start date

Apr 23, 2017

Status verified date

Apr, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patient Population The target population is both men and women of any age with advanced osteoarthritis of the glenohumeral joint who are considered by the treating surgeon to be a candidate for shoulder replacement. The type of arthritic process will not be considered a deciding factor. The arthritis must be amenable to treatment using either a humeral head replacement (stemmed or stem-less), or a standard total shoulder replacement.

Inclusion Criteria

1. Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:

1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
3. Activity modification
2. Patients will present with a glenoid retroversion between 10-26 degrees.
3. Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, with or without glenoid cartilage loss.
4. Age 18 years or older

Exclusion Criteria

1. < 10 degrees / > 27 degrees of glenoid retroversion
2. Active joint or systemic infection
3. Rotator cuff arthropathy
4. Significant muscle paralysis
5. Charcot's arthropathy
6. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
7. Unable to understand the consent form/process
8. Pregnancy
9. Psychiatric illness that precludes informed consent
10. Unwilling to be followed for the duration of the study
11. Retroversion cannot be surgically corrected to within 10 degrees of neutral
12. History of previous shoulder surgery on affected side
13. Rheumatoid arthritis in the affected shoulder

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Participants with 10-15 degrees of glenoid retroversion

active comparator: Participants with >15 degrees of glenoid retroversion

Interventions

Eccentric Reaming

Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within < 10 degrees of neutral glenoid version.

Augmented Glenoid Component Implantation

Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.

Posterior Glenoid Bone Grafting

Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.

Primary outcome measure

  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 24-Months ]
  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 5-Years Post-Operative ]

Central Contacts and Locations

Central contacts

Katie McIlquham

613-737-8899

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Principal Investigator:

Peter Lapner, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 30, 2024

Last verified

Apr, 2024

Keywords

  • Surgical Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-04-30.