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G7 Acetabular System vs. Exceed ABT Acetabular System in THA (G7)

Primary Purpose

Osteoarthritis Arthritis, Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
G7
Exceed ABT
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Arthritis focused on measuring G7 Acetabular System

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
  2. Rheumatoid arthritis.
  3. Correction of functional deformity.
  4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
  5. Revision of previously failed total hip arthroplasty.
  6. age over 20 years old

Exclusion Criteria:

  1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. osteoporosis,
  3. metabolic disorders which may impair bone formation,
  4. osteomalacia,
  5. distant foci of infections which may spread to the implant site,
  6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
  7. vascular insufficiency, muscular atrophy, or neuromuscular disease.

Sites / Locations

  • Kyunghee Univ. Hospital
  • Samsung Medical Center
  • Korea Univ. Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hip implant1

Hip implant2

Arm Description

The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications.

The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).

Outcomes

Primary Outcome Measures

the safety and effectiveness of patients (Harris Hip Score)
Harris Hip Score

Secondary Outcome Measures

Gruen zone analysis
Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system
Loosening on its implant
The presence of signs of loosening on its implant
Squeaking sounds
Number of patients with squeaking Sounds
Dislocation
Dislocation at different follow-up visits

Full Information

First Posted
January 8, 2015
Last Updated
March 25, 2019
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT02340390
Brief Title
G7 Acetabular System vs. Exceed ABT Acetabular System in THA
Acronym
G7
Official Title
A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED TRIAL TO EVALUATE G7 Acetabular System With CoC ARTICULATION COMPARED TO EXCEED ABT Acetabular System With CoC ARTICULATION IN TOTAL HIP ARTHROPLASTY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem compared to patients who received the Exceed ABT Acetabular system with the same combination
Detailed Description
This study will be a multi-center randomized controlled study. Eligible patients will be randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes, operative information, postoperative clinical outcome, radiographic assessment, incidence of squeaking, incidence of dislocation, implant survivorship and adverse events will be collected prospectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Arthritis, Rheumatoid Arthritis
Keywords
G7 Acetabular System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip implant1
Arm Type
Experimental
Arm Description
The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications.
Arm Title
Hip implant2
Arm Type
Experimental
Arm Description
The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
Intervention Type
Device
Intervention Name(s)
G7
Intervention Description
The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.
Intervention Type
Device
Intervention Name(s)
Exceed ABT
Intervention Description
The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
Primary Outcome Measure Information:
Title
the safety and effectiveness of patients (Harris Hip Score)
Description
Harris Hip Score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Gruen zone analysis
Description
Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system
Time Frame
Immediate post-op, 6 months, 1 year, 2 year
Title
Loosening on its implant
Description
The presence of signs of loosening on its implant
Time Frame
Immediate post-op, 6 months, 1 year, 2 year
Title
Squeaking sounds
Description
Number of patients with squeaking Sounds
Time Frame
6 months, 1 year, 2 year
Title
Dislocation
Description
Dislocation at different follow-up visits
Time Frame
6 months, 1 year, 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. Revision of previously failed total hip arthroplasty. age over 20 years old Exclusion Criteria: uncooperative patient or patient with neurologic disorders who are incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and vascular insufficiency, muscular atrophy, or neuromuscular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Joon Yoo, Ph.D
Organizational Affiliation
Seoul Nat'l Univ. Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kee-Hyung Rhyu, Ph.D
Organizational Affiliation
Kyung Hee Uni. Hospital at Gangdong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung-Jae Lim, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung-Bum Han, Ph.D
Organizational Affiliation
Korea Uni. Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyunghee Univ. Hospital
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea Univ. Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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G7 Acetabular System vs. Exceed ABT Acetabular System in THA

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