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

NCT02836262 | Recruiting DMC

• 1 other identifier: HIT-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (2)

• 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.

  between pre-operative and 730 days (24 months)

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

  between pre-operative and 730 days (24 months)

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

HIT Hip Replacement System (HRS)

EXPERIMENTAL

Single group assignment with historical controls.

Device: HIT Hip Replacement System

Interventions

HIT Hip Replacement System DEVICE

HIT Hip Replacement System

HIT Hip Replacement System (HRS)

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hip Innovation Technology: lead

Study Sites (1)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  Orthopaedic Innovation Centre

  PRINCIPAL INVESTIGATOR

• Branko Kopjar, MD, PhD

  Nor Consult, LLC

  STUDY DIRECTOR

Central Study Contacts

Linda Braddon, PhD

CONTACT

770-837-2681; LGB@SecureBME.com

Thomas Turgeon, MD

CONTACT

204-926-1218; tturgeon@cjrg.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 18, 2016
• Study Start: August 25, 2017
• Primary Completion: August 25, 2025
• Study Completion (Estimated): August 25, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)