Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty ((HRS-P))
Primary Purpose
Osteoarthritis of Hip
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIT Hip Replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Hip
Eligibility Criteria
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:
- 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.
Sites / Locations
- Orthopaedic Innovation CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIT Hip Replacement System (HRS)
Arm Description
Single group assignment with historical controls.
Outcomes
Primary Outcome Measures
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.
Change in Harris Hip Score between baseline (pre-operative) and the 730-day post-operative follow-up time point.
Secondary Outcome Measures
Change in Oxford Hip Score between 730-day 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)
Full Information
NCT ID
NCT02836262
First Posted
July 14, 2016
Last Updated
December 9, 2022
Sponsor
Hip Innovation Technology
1. Study Identification
Unique Protocol Identification Number
NCT02836262
Brief Title
Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
Acronym
(HRS-P)
Official Title
A Multi-Center Prospective Study of the Hip Innovation Technology (HIT) Hip Replacement System in Primary Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
August 25, 2023 (Anticipated)
Study Completion Date
August 25, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hip Innovation Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIT Hip Replacement System (HRS)
Arm Type
Experimental
Arm Description
Single group assignment with historical controls.
Intervention Type
Device
Intervention Name(s)
HIT Hip Replacement System
Intervention Description
HIT Hip Replacement System
Primary Outcome Measure Information:
Title
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)
Title
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 Outcome Measure Information:
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Braddon, PhD
Phone
770-837-2681
Email
LGB@SecureBME.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Turgeon, MD
Phone
204-926-1218
Email
tturgeon@cjrg.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Organizational Affiliation
Orthopaedic Innovation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Branko Kopjar, MD, PhD
Organizational Affiliation
Nor Consult, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Orthopaedic Innovation Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
Phone
(204) 926-1218
Email
tturgeon@cjrg.ca
First Name & Middle Initial & Last Name & Degree
Sarah Tran
Phone
(204) 926-1231
Email
stran@orthoinno.com
First Name & Middle Initial & Last Name & Degree
Thomas Turgeon, MD
12. IPD Sharing Statement
Learn more about this trial
Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
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