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NCT Number: NCT05393778

Measured vs Navigated Techniques in Total Hip Arthroplasty

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measured Technique

Procedure

Manual intra-operative checks and tools are used to aid in component placement during surgery.

Navigated Technique

Procedure

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.

Primary outcomes

  1. Change in Pain Assessment - Oxford Hip Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 90 days post-operatively

    Serious adverse events will be monitored. This includes:

    • Wound complication
    • Dislocation
    • Fracture
    • Infection
    • Re-operation
    • Revision surgery

Secondary outcomes

  1. Accuracy of reconstruction (in mm)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • FormusLab

Registry information

Official study title

Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 26, 2022
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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