Clincosm LogoSign in Get a demo

Measured vs Navigated Techniques in Total Hip Arthroplasty

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05393778
Collaborator
FormusLab (Other)
100
Enrollment
2
Arms
26.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Measured Technique
  • Procedure: Navigated Technique
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Measured Technique

Patients in this group will have pre-operative planning done using the measured technique.

Procedure: Measured Technique
Manual intra-operative checks and tools are used to aid in component placement during surgery.
Experimental: Navigated Technique

Patients in this group will have pre-operative planning done using the navigated technique.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Assessment - Oxford Hip Score [once pre-operatively and once one-year post-operatively]

    The Oxford Hip Score will be given to patients to assess subjective measures of hip pain. Scores for each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome

  2. Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol [once pre-operatively and once one-year post-operatively]

    the EuroQol (EQ-5D-5L) will be given to patients to assess subjective measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

  3. Change in physical, mental, and social health- PROMIS Global-10 [once pre-operatively and once one-year post-operatively]

    the PROMIS Global-10 will be given to patients to assess subjective measures of physical, mental and social health. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores indicate worse physical and mental health

  4. Adverse Events [90 days post-operatively]

    Serious adverse events will be monitored. This includes: Wound complication Dislocation Fracture Infection Re-operation Revision surgery

Secondary Outcome Measures

  1. Accuracy of reconstruction (in mm) [post-operatively (within one week post-operatively)]

    A measure (in mm) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using: Acetabular component orientation Accuracy of acetabular component orientation o Accuracy of femoral version restoration Combined version of arthroplasty in degrees Accuracy of combined version restoration Femoral Offset in mm o Accuracy of achieving femoral offset Acetabular offset in mm o Accuracy of achieving acetabular offset Total offset in mm o Accuracy of achieving total offset Leg Length in mm o Accuracy of achieving leg length

  2. Comparison of margin of error [Through study completion, an average of 1 year]

    This outcome will measure what the margin of error is between intra-operatively measured values and those determined from the post-operative CT scan. This will be done using statistical analysis of data for patients in both study arms.

  3. Accuracy of reconstruction on outcome [Through study completion, an average of 1 year]

    This outcome measure will assess the accuracy of reconstruction correlate with outcome (adverse events and PROMs). This will be done by analyzing accuracy as depicted by the variables in outcome measure 5, and how these measures of accuracy correlate to patient reported outcome measure scores and rates of adverse events

  4. Accuracy of reconstruction (in degrees) [post-operatively (within one week post-operatively)]

    A measure (in degrees) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using: Acetabular component orientation (Radiographic inclination/anteversion in degrees as per Murray) Accuracy of acetabular component orientation (i.e. deviation from target - aim for deviation of < ±5˚) ● Femoral Component Version in degrees Accuracy of femoral version restoration (aim for version difference to be less than ±5˚ from pre-operative plan) ● Combined version of arthroplasty in degrees Accuracy of combined version restoration (sum of acetabular and femoral version; aim for combined version to be less than ±10˚ from pre-operative plan)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ottawa Hospital Research Institute
  • FormusLab

Investigators

  • Principal Investigator: George Grammatopoulos, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT05393778
Other Study ID Numbers:
  • 3390
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis, Hip

Study Results

No Results Posted as of May 26, 2022