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Safety and Effectiveness of the HIT Reverse HRS

Primary Purpose

Degenerative Joint Disease, Osteoarthritis, Hip, Avascular Necrosis of Hip

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Innovation Technology Reverse Hip Replacement System
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
Sponsored by
Hip Innovation Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Joint Disease focused on measuring total hip arthroplasty

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.
  • Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
  • Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
  • Patient has a signed and dated Informed Consent Form (ICF).
  • 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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
  • Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
  • Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
  • Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
  • Patient has a known allergy to titanium and/or XLPE.
  • Patient has known metal sensitivities to cobalt chromium (CoCr).
  • Patient has a history of septic arthritis in the index joint.
  • Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is 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 judgment).
  • 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 5 years, except for 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 Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
  • Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.
  • Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).
  • Patient has a Body Mass Index (BMI) of 40 or higher.
  • Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.
  • Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care.
  • Patient is currently pregnant or is planning to become pregnant during the study.
  • Patient is a competitive or professional athlete.

Sites / Locations

  • Division of Orthopaedic SurgeryRecruiting
  • JIS OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm - HIT Reverse HRS

Control Arm

Arm Description

Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.

Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination.

Outcomes

Primary Outcome Measures

OHS of 36 or more at the 2-year follow-up visit
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Radiologic success at the 2-year follow-up
Defined as No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones; No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; No acetabular cup inclination change greater than 4 degrees from baseline.
Absence of revision at the 2-year follow-up visit
No reoperations that led to removal or replacement of any of the acetabular or femoral components.

Secondary Outcome Measures

Change in OHS compared to baseline at all follow-up visits.
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Change in HHS compared to baseline at all follow-up visits.
The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points). Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.

Full Information

First Posted
April 20, 2022
Last Updated
April 11, 2023
Sponsor
Hip Innovation Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05357378
Brief Title
Safety and Effectiveness of the HIT Reverse HRS
Official Title
Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
July 15, 2026 (Anticipated)
Study Completion Date
July 15, 2035 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
Detailed Description
This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm: DePuy Synthes Corail® Total Hip System in combination with Pinnacle® Complete Acetabular Hip System; Zimmer Biomet Taperloc® Complete Hip System in combination with G7® Acetabular System; Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup; Smith & Nephew Anthology® Total Hip System in combination with R3® Acetabular System. Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease, Osteoarthritis, Hip, Avascular Necrosis of Hip, Traumatic Arthropathy-Hip
Keywords
total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm - HIT Reverse HRS
Arm Type
Experimental
Arm Description
Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Subjects in the Control Arm will receive one of the already-marketed semi- constrained uncemented hip systems using a metal-on-highly-cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination.
Intervention Type
Device
Intervention Name(s)
Hip Innovation Technology Reverse Hip Replacement System
Other Intervention Name(s)
HIT Reverse HRS
Intervention Description
Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
Intervention Type
Device
Intervention Name(s)
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
Other Intervention Name(s)
DePuy Synthes Corail® Total Hip System in combination with Pinnacle® Complete Acetabular Hip System., Zimmer Biomet Taperloc® Complete Hip System in combination with G7® Acetabular System., Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup., Smith & Nephew Anthology® Total Hip System in combination with R3® Acetabular System.
Intervention Description
Control Arm subjects will receive one of the already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. DePuy Synthes Corail® Total Hip System in combination with Pinnacle® Complete Acetabular Hip System. Zimmer Biomet Taperloc® Complete Hip System in combination with G7® Acetabular System. Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup. Smith & Nephew Anthology® Total Hip System in combination with R3® Acetabular System.
Primary Outcome Measure Information:
Title
OHS of 36 or more at the 2-year follow-up visit
Description
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Time Frame
24 months
Title
Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.
Description
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Time Frame
24 months
Title
Radiologic success at the 2-year follow-up
Description
Defined as No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones; No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; No acetabular cup inclination change greater than 4 degrees from baseline.
Time Frame
24 months
Title
Absence of revision at the 2-year follow-up visit
Description
No reoperations that led to removal or replacement of any of the acetabular or femoral components.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in OHS compared to baseline at all follow-up visits.
Description
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Time Frame
24 months
Title
Change in HHS compared to baseline at all follow-up visits.
Description
The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points). Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Exploratory Endpoints: OHS at all follow-up visits
Description
The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).
Time Frame
10 year
Title
Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) at all follow-up visits.
Description
The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points). Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
Time Frame
10 year
Title
Exploratory Endpoints: Device survivorship
Description
Device survivorship is measured as a cardinal event. Any reoperation in which the entire device or part of the device has been removed or replaced will be defined as a device revision.
Time Frame
10 year
Title
Exploratory Endpoints: Radiographic evaluation of linear penetration of the femoral head at the 2-year follow-up visit.
Description
This study requires anteroposterior (AP)-pelvis and lateral (frog-leg or Lauenstein position) views obtained in the supine position on all subjects. An additional AP-hip image will be needed only if the AP-pelvis cannot provide a complete implant image. Radiographs will be obtained at the immediate postoperative follow-up (AP-pelvis only), and at the 6-week, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, and 10-year follow-up visits. Radiographs will be transferred to the Central Radiology Lab for processing and evaluation by an independent radiologist.
Time Frame
10 year
Title
Exploratory Endpoints: Metal ion level assessment of titanium, cobalt, and chromium.
Description
All subjects will have baseline metal ion level (Ti, Co, and Cr) identified before study THA. Further, all subjects will be monitored for metal ions (Ti, Co, and Cr) at 1-, 2-, 3-, 4-, 5-, 7-, and 10-year follow-up visits.
Time Frame
10 year
Title
Exploratory Endpoints: Subject Satisfaction with Outcome.
Description
Subject Satisfaction with Outcome will be evaluated at the 1, 2-, 3-, 4- 5-, 7- and 10-year follow-up visits using a 4-point ordinal scale. The questionnaire will ask subjects how satisfied they are with the outcome of the surgery. The available answers will include: Very Satisfied (4); Somewhat Satisfied (3); Somewhat Dissatisfied (2); and Very Dissatisfied (1).
Time Frame
10 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA. Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment. Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk. Patient has a signed and dated Informed Consent Form (ICF). 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 received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months. Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10. Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months. Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months. Patient has a known allergy to titanium and/or XLPE. Patient has known metal sensitivities to cobalt chromium (CoCr). Patient has a history of septic arthritis in the index joint. Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is 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 judgment). 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 5 years, except for 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 Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia. Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology. Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment). Patient has a Body Mass Index (BMI) of 40 or higher. Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery. Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care. Patient is currently pregnant or is planning to become pregnant during the study. Patient is a competitive or professional athlete.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Diamantoni
Phone
1-866-832-4471
Email
g.diamantoni@hit-irh.com
Facility Information:
Facility Name
Division of Orthopaedic Surgery
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Zabinski
Phone
609-226-9560
Email
sjzabinski@comcast.net
First Name & Middle Initial & Last Name & Degree
Valerie Paul
Phone
609-927-1999
Email
vpaul@shoreorthodocs.com
Facility Name
JIS Orthopedics
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A Crawford, MD
Phone
614-221-6331
Email
CrawfordDA@jisortho.com
First Name & Middle Initial & Last Name & Degree
Michael Sneller
Phone
614-964-0348
Email
snellerma@jisortho.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27286675
Citation
Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
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Safety and Effectiveness of the HIT Reverse HRS

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