Trials / Unknown
UnknownNCT05393778
Measured vs Navigated Techniques in Total Hip Arthroplasty
Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Measured Technique | Manual intra-operative checks and tools are used to aid in component placement during surgery. |
| PROCEDURE | Navigated Technique | IntelliJoint® navigation is an imageless-based navigation system that utilizes a miniature infrared camera and microelectronics to measure hip center of rotation, acetabular inclination and version, leg length, and offset. The device provides accurate real-time data on implant positioning to aid in placement of the components during surgery. |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2024-07-01
- Completion
- 2024-09-01
- First posted
- 2022-05-26
- Last updated
- 2022-05-26
Source: ClinicalTrials.gov record NCT05393778. Inclusion in this directory is not an endorsement.