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Approach to Glenoid Management in Shoulder Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT02966886
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The primary objective of this study is to determine the difference in disease specific quality of life outcome measures between patients diagnosed with osteoarthritis of the shoulder joint whom require a total shoulder arthroplasty (TSA) between the following study arms: 1)TSA using an augmented component compared with TSA using a standard component with eccentric reaming in patients or 2) TSA using an augmented component compared with posterior bone grafting.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Shoulder Procedure: Eccentric Reaming Procedure: Augmented Glenoid Component Implantation Procedure: Posterior Glenoid Bone Grafting Not Applicable

Detailed Description:

Patients who have 10-15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with eccentric glenoid reaming or TSA with augmented glenoid component implantation.

Patients whose condition involves > 15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups: TSA with augmented glenoid component implantation or posterior glenoid bone grafting.

The primary objective will be measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score pre-operatively and at post-operative time intervals (i.e.. 3, 6, 12 and 24 months).

Secondary Objectives: i) To determine the survivorship of the components as measured by the degree of radiographic lucencies and component alignment determined by a CT scan at 1 and 5 years post-surgery between study arms in both age groups.

ii) To determine the difference in disease specific quality of life between treatment allocations in both age groups as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the EuroQol Group EQ-5D-5L score pre-operatively and at post-operative time intervals (ie. 3, 6, 12 and 24 months) (See Appendix A) as well as adverse events, and health care utilization.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Techniques in the Management of Glenoid Deficiencies in Shoulder Arthroplasty: Protocol
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Eccentric Reaming versus Augmented Component

All patients will undergo treatment with shoulder arthroplasty. Patients with 10-15 degrees of retroversion, will be randomly assigned to one of two standard of care treatment groups:

Total Shoulder Arthroplasty with Eccentric Glenoid 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.

Total Shoulder Arthroplasty with 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.

Procedure: 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.

Procedure: 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.

Active Comparator: Augmented Component versus Bone Grafting

All patients will undergo treatment with shoulder arthroplasty. Patients with >15 degrees of retroversion will be randomly assigned to one of two standard of care treatment groups:

Total Shoulder Arthroplasty with 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.

Procedure: 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.

Procedure: 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 Measures :
  1. Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score [ Time Frame: 24 months post-op ]
    The WOOS is a clinical outcome tool specific for osteoarthritis of the shoulder, it is highly sensitive to small but clinically significant changes in patient function


Secondary Outcome Measures :
  1. the Constant score [ Time Frame: 3, 6, 12 and 24 months post-op ]
    The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system calculated from a self-assessment portion that evaluates pain and ability to perform tasks of daily living, and a clinical assessment which tests active range of shoulder motion and strength.

  2. the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES) [ Time Frame: 3, 6, 12 and 24 months post-op ]
    The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL).

  3. EuroQol EQ-5D-5L [ Time Frame: 3, 6, 12 and 24 months post-op ]
    The EuroQol EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100).

  4. Shoulder Health Utilization Assessment Form [ Time Frame: 3, 6, 12 and 24 months post-op ]
    The Health Utilization Form collecting healthcare information post-op.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who have failed standard non-surgical management of their shoulder arthritis 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 type B2 glenoid deficiency, as defined by the Walch classification system, with greater than 10 degrees of retroversion.
  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. Walch B2 glenoid with less than 10 degrees of 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 then 1 year or unacceptably high operative risk)
  7. Unable to speak or read English/French
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966886


Contacts
Contact: Peter Lapner, MD 613-737-8899 ext 78377 plapner@toh.ca
Contact: Research Team 6137378920

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Peter Lapner, MD    6137378899 ext 78377    plapner@toh.on.ca   
Principal Investigator: Peter Lapner, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Peter Lapner, MD OHRI

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02966886     History of Changes
Other Study ID Numbers: 2016-0779
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:
Surgical Management

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases