Skip to content

Accuracy of robotically enhanced glenoid prosthesis positioning for total shoulder arthroplasty.

Accuracy of robotically enhanced glenoid prosthesis positioning for patients undergoing total shoulder arthroplasty

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001378415
Enrollment
30
Registered
2025-12-09
Start date
2026-02-05
Completion date
2026-04-28
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate the effectiveness of a robotic-assisted approach in accurately placing the glenoid component during reverse total shoulder arthroplasty (rTSA) surgery. We aim to determine whether the use of the Mako robotic system can lead to better surgical outcomes compared to traditional patient-specific instrumentation methods. Our hypothesis is that robotic assistance will improve the precision of glenoid component placement, resulting in fewer errors and better functional recovery for patients. This study will assess key outcomes such as the accuracy of glenoid placement, the range of motion in the shoulder, and overall patient satisfaction after surgery. By understanding the benefits of robotic technology in shoulder surgery, we hope to enhance surgical techniques and improve long-term results for individuals requiring shoulder replacements. Participants in this study will contribute to groundbreaking research that could change how shoulder surgeries are performed in the future.

Interventions

Robotic-Assisted vs. Patient-Specific Instrumentation in Reverse Total Shoulder Arthroplasty Arm 1: Robotic-Assisted Reverse Total Shoulder Arthroplasty (rTSA) - Intervention materials: MAKO robotic system equipped with advanced imaging and guidance systems for precise glenoid component implantation. Surgeons will utilize patient imaging data to map surgical plans pre operatively and to set parameters for alignment referencing used by the MAKO robot during surgery. Specifically, the MAKO assis

Robotic-Assisted vs. Patient-Specific Instrumentation in Reverse Total Shoulder Arthroplasty Arm 1: Robotic-Assisted Reverse Total Shoulder Arthroplasty (rTSA) - Intervention materials: MAKO robotic system equipped with advanced imaging and guidance systems for precise glenoid component implantation. Surgeons will utilize patient imaging data to map surgical plans pre operatively and to set parameters for alignment referencing used by the MAKO robot during surgery. Specifically, the MAKO assists the surgeon to determine more accurate preparation of glenoid bone.. - Procedures and Activities: The procedure will involve the utilization of robotic assistance during glenoid component placement. Surgeons, trained on the MAKO system, will follow standardized surgical protocols while implementing robotic assistance. - Personnel delivering the intervention: An orthopedic surgeon specializing in shoulder arthroplasty with at least 5 years of experience in robotic surgical techniques will lead the procedure. Prior to commencing this study, the investigative surgeon completed a learning curve of 20 patients. The learning curve for this procedure has not been accurately determined however for other robotic procedures such as hip and Knee arthroplasty, the Learning Curve is 7-9 cases. - Mode of Delivery: The intervention will be delivered face-to-face in an operating room setting. Each surgery will occur individually. - Frequency and Duration: Participants will undergo a single surgical intervention during the study, with follow-up assessments conducted at 2 years post-operatively. - Location: The surgery will take place in a hospital operating theatre setting. - Personalization/Adaptation of Intervention: Both interventions aim to implement precise positioning of the glenoid component based on pre-operational imaging. This will enable adaptation based on individual anatomical complexities, particularly in Arm 1 with robotic guidance that can be adjusted intraoperatively depending on real-time imaging feedback. -Intervention Adherence and Fidelity Assessment: Adherence to surgical protocols will be monitored by researchers through checklists that include confirming robotic setup, imaging alignment, and adherence to pre-operative plans. Training education for surgical staff on new technologies will be conducted to enhance fidelity in intervention delivery, improving consistency in procedure execution. Allocation to the intervention group (A) will be 15 consecutive recruitments and then subsequent recruitment to group B (control)

Sponsors

Orthopaedic Research Institute of Queensland
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria • Patients scheduled to undergo primary reverse rTSA for the treatment of osteoarthritis or rotator cuff arthropathy of the shoulder joint, with radiographic evidence of the need for arthroplasty. Prior non-arthroplasty surgical intervention on the affected shoulder is not considered an exclusion criterion for this study. • Male and female • Age 40-90 • Able to provide informed consent • BMI <40

Exclusion criteria

Exclusion criteria • Patients unable to comply with assessment requirements. • Patients unable to provide informed consent. • Patients who are pregnant or planning to become pregnant within the duration of the study period. • Patients with BMI >40 • Patients with active infection • Patients with significant other orthopaedic deformities, anatomical disruption/distortion of the shoulder joint other than that caused by OA or rotator cuff arthropathy. • Patients undergoing TSA for management of proximal humerus fracture • The patient is medically unfit for surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026