N/A
N=44
Patient Specific Instruments Versus Standard Surgical Instruments
Total Shoulder Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01430468 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Comparing Glenoid Component Positioning to Pre Operative Planning — 4.3; 6.9 Degrees — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glenoid Positioning System (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing Glenoid Component Positioning to Pre Operative Planning |
4.3; 6.9 | 0.11 |
| SECONDARY Intra-operative Photographs |
0; 0 | — |
Summary
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Eligibility Criteria
Inclusion Criteria
- All patients otherwise indicated for primary reverse or anatomic total shoulder replacement that are able to get a pre-operative CT scan at the Cleveland Clinic will be considered eligible for enrollment. All patients will be consented in the office as part of the pre-operative consent for surgery and all will need to randomization at the time of surgery
Exclusion Criteria
- Patients will be excluded if they have significant metal in the joint that results in metal artifact on the CT scan, thereby compromising the ability to visualize the glenoid on the pre-operative simulator.
Data sourced from ClinicalTrials.gov (NCT01430468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.