CClinicalTrials.gg
RecruitingNCT02836262(HRS-P)Updated Sep 21, 2026

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

An interventional study of HIT Hip Replacement System in Osteoarthritis of Hip, sponsored by Hip Innovation Technology. Recruiting at 1 site in Canada. Open to participants aged 65 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Hip Innovation Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
65 Years to 79 Years
Sex
All
01

Study summary

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.

Read the detailed description

The HIT Hip Replacement System (HHRS) is a Metal-on-Polyethylene (MoP) conventional hip prosthesis. The HHRS consists of a femoral stem, an acetabular cup and a Cobalt Chromium Molybdenum (CoCrMo) ball that articulates within a polyethylene liner. The ball sits on the acetabular cup, and the polyethylene liner is attached to the femoral cup, which attaches to the femoral stem, instead of the acetabular cup. The acetabular component of the HHRS consists of a hemispherical acetabular shell with a clustered screw-hole design. The outside of the shells are coated with titanium plasma to facilitate bone in-growth and provide secure intermediate fixation with the prepared bone surface at the site of implantation. The acetabular cup has a 3-hole design that accommodates three titanium alloy bone screws. Inside the acetabular cup is a male taper for assembly with the acetabular ball. The femoral component consists of a femoral stem manufactured from titanium and a mating cobalt chrome femoral cup lined with a highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE). As with the acetabular cup, the femoral stem is porous coated using a plasma spray of pure titanium, which is intended to facilitate bone in-growth and provide secure intermediate fixation with the prepared bone surface at the site of implantation. The femoral stem incorporates a female taper for assembly with the male taper of the femoral cup.

The device has undergone extensive pre-clinical testing. There is no clinical experience with the HRS.

02

Conditions studied

  • Osteoarthritis of Hip

Browse trials for

03

Who can participate

Ages eligible
65 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • Signed and dated informed consent document.
  • Patient is willing and able to participate in required follow-up visits at the Investigational site and to complete study procedures and questionnaires.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible;
  • Patient has total or partial absence of the muscular or ligamentous apparatus;
  • Patient has known moderate to severe renal insufficiency;
  • Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's discretion);
  • Patient has a deformity of the affected limb or significant anatomic variance of the affected hip;
  • Patient has an active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study;
  • Patient has any condition which may, in the opinion of the Investigator, interfere with the total hip replacement survival or patient outcomes (e.g. Paget's disease, Charcot's disease);
  • Patient has rheumatoid arthritis or other autoimmune condition that affect joints (e.g. Lupus Arthritis);
  • Patient has any condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion);
  • Body Mass Index (BMI) of 40 or more;
  • Patient has an active infection (e.g. hepatitis, AIDS, ARC) - systemic or at the site of intended surgery;
  • Patient is currently participating in any investigational study not related to this study's pre-operative or post-operative care;
  • Patient has any other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the Investigator, which would make the patient inappropriate for entry into this study;
  • Patient has a history of metabolic bone disease (e.g. Paget's disease or osteomalacia);
  • Patient is currently pregnant or is planning to become pregnant.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    HIT Hip Replacement System (HRS)

    Single group assignment with historical controls.

    Device: HIT Hip Replacement System

Interventions

  • DeviceHIT Hip Replacement System

    HIT Hip Replacement System

05

What researchers measure

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)

06

Study locations

1 of 1 sites recruiting
  • Orthopaedic Innovation Centre
    Winnipeg, Manitoba R2K 2M9, Canada
    Recruiting
07

Registry details

Key details

Study ID
NCT02836262
Lead sponsor
Hip Innovation Technology
Responsible party
Sponsor
First posted
Jul 18, 2016
Start date
Aug 25, 2017
Primary completion
Sep 16, 2029 (estimated)
Completion
Sep 16, 2032 (estimated)
Last update
Sep 21, 2026

Study contacts

Linda Braddon, PhD
Contact
LGB@SecureBME.com
770-837-2681
Thomas Turgeon, MD
Contact
tturgeon@cjrg.ca
204-926-1218
Thomas Turgeon, MD
principal investigator · Orthopaedic Innovation Centre
Branko Kopjar, MD, PhD
study director · Nor Consult, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion