Health TrialsbyHealthPanel

Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty

ConditionOsteoarthritis of Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-79
SponsorHip Innovation Technology

About this trial

To evaluate effectiveness and safety of HHRS in subjects undergoing total hip arthroplasty (THA). Effectiveness will be evaluated using patient-reported, clinical, radiologic, and radiostereometric outcomes. Safety will be evaluated through the collection of device-related and unanticipated device-related adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has a non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary total hip replacement.

Age between 65 and 79 years (inclusive) at the time of enrollment.

Patient is a suitable candidate for primary total hip replacement at the discretion of the Investigator.

Pre-surgery (within 28 days before surgery) WOMAC Global Score of 40 or larger on a scale from 0 (best) to 96 (worst)

Disqualifiers

Patient has had total hip replacement, hemi-arthroplasty, or fusion in either hip in the last 12 months;

Patient has planned total hip arthroplasty on a contra-lateral joint in the next 12 months;

Patient has a known allergy to any component of the study device;

Patient has a history of active sepsis in the joint;

Trial design

Design model

Single group

Treatments tested in this trial

  • HIT Hip Replacement System

    Device

    HIT Hip Replacement System

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: HIT Hip Replacement System (HRS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) v3.0 Likert Scale Functional Limitations Score between baseline (pre-operative) and the 730- day post-operative follow-up time point.

Time frame
between pre-operative and 730 days (24 months)
2

Change in Harris Hip Score between baseline (pre-operative) and the 730-day post-operative follow-up time point.

Time frame
between pre-operative and 730 days (24 months)

Secondary outcomes

1

Change in Oxford Hip Score between 730-day post-operative and baseline (pre-surgery)

Time frame
between 730-days post-operative and baseline (pre-surgery)
2

Change in Short Form 36 v2 Physical Component Score (PCS) between 730-days post-operative and baseline (pre-surgery)

Time frame
between 730-days post-operative and baseline (pre-surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hip Innovation Technology

Lead sponsor

Source ClinicalTrials.gov
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