None listed
Conditions
Brief summary
The aim of this study is to compare the accuracy of the glenoid placement with use of patient specific, image-derived instrumentation to that of standard instrumentation in reverse total shoulder arthroplasty. There will be two study groups: Group 1 (n=25), Conventional surgical technique (without guides) Group 2 (n=25), Patient specific, use of image derived instrumentation guides. The null hypothesis for this study is that the use of patient specific guides for the glenoid component positioning will make no difference in the accuracy of component placement. A total of 50 patients will be recruited for the study. Sites for the study include Townsville Hospital and Health Services and Mater Health Services North Queensland Ltd.
Interventions
Use of patient-specific, image-derived instrumentation for glenoid prosthesis positioning in reverse total shoulder arthroplasty. Custom, 3D-printed jigs are produced from Computed Tomography (CT) imaging of the participant's affected shoulder, through digital planning technology (Materialise NV). Patient undergoes a CT, Materialise produce a planned template for the implant positioning for which the surgeon approves. Jigs are manufactured through 3D printing and provided for the day of surge
Use of patient-specific, image-derived instrumentation for glenoid prosthesis positioning in reverse total shoulder arthroplasty. Custom, 3D-printed jigs are produced from Computed Tomography (CT) imaging of the participant's affected shoulder, through digital planning technology (Materialise NV). Patient undergoes a CT, Materialise produce a planned template for the implant positioning for which the surgeon approves. Jigs are manufactured through 3D printing and provided for the day of surgery. These jigs are then used intra-operatively by consultant surgeons to aid proper positioning of the component. Participants are recruited from those undergoing shoulder arthroplasty under the care of the investigating surgeons. Verification of implant positioning will be performed by the patient undergoing a Postoperative CT at 6 weeks after surgery.
Sponsors
The Orthopaedic Research Institute of Queensland (ORIQL)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
- Scheduled for reverse total shoulder replacement for primary arthritis of the shoulder joint, with radiographic evidence of the need for arthroplasty. - Able to provide informed consent - BMI <40
Exclusion criteria
- Unable to comply with assessment requirements - Unable to provide informed consent - Pregnant, or planning to become pregnant within the duration of the study period. - BMI >40 - Active infection - Significant other orthopaedic deformities, anatomical disruption/distortion of the shoulder joint other than that caused by OA. - Undergoing RTSA for management of proximal humerus fracture.
Outcome results
None listed