Clinical trial NCT05393778: Measured vs Navigated Techniques in Total Hip Arthroplasty
Official title: Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: FormusLab
First posted: 2022-05-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Pain Assessment - Oxford Hip Score
timeFrame: once pre-operatively and once one-year post-operatively
measure: Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol
timeFrame: once pre-operatively and once one-year post-operatively
measure: Change in physical, mental, and social health- PROMIS Global-10
timeFrame: once pre-operatively and once one-year post-operatively
measure: Adverse Events
timeFrame: 90 days post-operatively
Secondary outcomes:
measure: Accuracy of reconstruction (in mm)
timeFrame: post-operatively (within one week post-operatively)
measure: Comparison of margin of error
timeFrame: Through study completion, an average of 1 year
measure: Accuracy of reconstruction on outcome
timeFrame: Through study completion, an average of 1 year
measure: Accuracy of reconstruction (in degrees)
timeFrame: post-operatively (within one week post-operatively)
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital
name: George Grammatopoulos, MD
role: PRINCIPAL_INVESTIGATOR
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