N/A
N=40
Two Year Study With Robotic-Arm Assisted Hip Surgery.
Surgery · Hip Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03891199 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Mar 2024
Primary outcome: Primary: Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. — 5.95; 4.26 degrees error in anteversion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robotic-Arm Assisted THA (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. |
5.95; 4.26 | — |
| PRIMARY Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. |
39.54; 47.92; 41.31; 48.40; 32.27; 59.17 | — |
| PRIMARY Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period. |
10.11; 11.37; 3.92; 2.88 | — |
| PRIMARY Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. |
4.73; 2.93 | — |
| PRIMARY Adherence to Lewinnek Safe Zone |
14; 16; 17; 17 | — |
Summary
This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
Eligibility Criteria
Inclusion Criteria
- Patients requiring primary total hip arthroplasty
- Patients willing and able to comply with follow-up requirements
- Patients willing to sign an Institutional Review Board approved informed consent form.
Exclusion Criteria
- Patients with Body Mass Index >45
- Patients who are <18 years of age
- Patients with an active infection or suspected latent infection in or about the hip joint
- Bone stock that is inadequate for support or fixation of the prosthesis
- Previous major hip surgery excluding hip arthroscopy
- Total hip arthroplasty using cement fixation or resurfacing
Data sourced from ClinicalTrials.gov (NCT03891199). 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.