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Participants with >15 degrees of glenoid retroversion for Shoulder Osteoarthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shoulder OsteoarthritisPosterior Glenoid Bone Grafting - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is being done to compare two different surgeries for shoulder osteoarthritis, in order to find out which one produces better outcomes.

Eligible Conditions
  • Shoulder Osteoarthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3, 6, 12 and 24 months post-op

24 months post-op
Western Ontario Osteoarthritis of the Shoulder Index (WOOS) score
Month 24
EuroQol EQ-5D-5L
Shoulder Health Utilization Assessment Form
the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
the Constant score

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
1
Autologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation
2
Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate

Trial Design

2 Treatment Groups

Participants with >15 degrees of glenoid retroversion
1 of 2
Participants with 10-15 degrees of glenoid retroversion
1 of 2

Active Control

216 Total Participants · 2 Treatment Groups

Primary Treatment: Participants with >15 degrees of glenoid retroversion · No Placebo Group · N/A

Participants with >15 degrees of glenoid retroversionActiveComparator Group · 2 Interventions: Posterior Glenoid Bone Grafting, Augmented Glenoid Component Implantation · Intervention Types: Procedure, Procedure
Participants with 10-15 degrees of glenoid retroversionActiveComparator Group · 2 Interventions: Augmented Glenoid Component Implantation, Eccentric Reaming · Intervention Types: Procedure, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 12 and 24 months post-op

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
529 Previous Clinical Trials
2,511,760 Total Patients Enrolled
Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital
12 Previous Clinical Trials
2,877 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients will present with a glenoid retroversion between 10-26 degrees.
You must be between the ages of 18 and 65 years.
References

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