Actively Recruiting

Phase Not Applicable
Age: 65Years - 79Years
All Genders
NCT02836262

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

Led by Hip Innovation Technology · Updated on 2025-04-01

100

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has a non-inflammatory degenerative joint disease or related diagnosis such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, or diastrophic variant requiring unilateral primary total hip replacement.
  • Age between 65 and 79 years (inclusive) at enrollment.
  • Patient is considered a suitable candidate for primary total hip replacement by the Investigator.
  • Pre-surgery WOMAC Global Score of 40 or higher (scale 0 to 96) within 28 days before surgery.
  • Signed and dated informed consent.
  • Patient is willing and able to participate in required follow-up visits and complete study procedures and questionnaires.
Not Eligible

You will not qualify if you...

  • Total hip replacement, hemi-arthroplasty, or fusion in either hip within the last 12 months.
  • Planned total hip arthroplasty on the opposite hip within the next 12 months.
  • Known allergy to any component of the study device.
  • History of active sepsis in the joint.
  • Insufficient acetabular or femoral bone stock preventing good implant anchorage.
  • Total or partial absence of the muscular or ligamentous apparatus.
  • Known moderate to severe renal insufficiency.
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg.
  • Deformity of the affected limb or significant anatomic variance of the affected hip.
  • Active malignancy or history of invasive malignancy within five years except certain treated skin cancers and cervix carcinoma in situ.
  • Conditions that may interfere with hip replacement survival or patient outcomes (e.g., Paget's disease, Charcot's disease).
  • Rheumatoid arthritis or autoimmune joint conditions (e.g., Lupus Arthritis).
  • Conditions interfering with self-assessment or patient-reported outcomes.
  • Body Mass Index of 40 or more.
  • Active infection systemically or at surgery site.
  • Participation in other investigational studies unrelated to this study's care.
  • Severe acute or chronic medical conditions interfering with study results.
  • History of metabolic bone disease.
  • Currently pregnant or planning pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Orthopaedic Innovation Centre

Winnipeg, Manitoba, Canada, R2K 2M9

Actively Recruiting

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Research Team

L

Linda Braddon, PhD

CONTACT

T

Thomas Turgeon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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