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Active Not Recruiting NCT05393778

Measured vs Navigated Techniques in Total Hip Arthroplasty

Conditions: Osteoarthritis, Hip

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Ottawa Hospital Research Institute

Location: The Ottawa Hospital Ottawa Ontario

Summary

Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.

Eligibility Criteria

Inclusion Criteria: * Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation. Exclusion Criteria: * Secondary OA due to Dysplasia (Hartofilakidis \>1) * Avascular necrosis of the hip with destruction of joint structure * Sequelae of Pediatric deformity with abnormal anatomy * Cemented fixation of femur or acetabulum * Previous arthroplasty-type procedure * Previous septic arthritis of the hip

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05393778). StuddyBuddy aggregates publicly available trial information.