G7 Acetabular System vs. Exceed ABT Acetabular System in THA

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340390
• Other study ID #: ORTHO.CR.GH42
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Osteoarthritis Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• G7
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.
• Exceed ABT
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).

Locations

Country	Name	City	State
Korea, Republic of	Korea Univ. Hospital	Seoul
Korea, Republic of	Kyunghee Univ. Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the safety and effectiveness of patients (Harris Hip Score)	Harris Hip Score	1 year
Secondary	Gruen zone analysis	Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system	Immediate post-op, 6 months, 1 year, 2 year
Secondary	Loosening on its implant	The presence of signs of loosening on its implant	Immediate post-op, 6 months, 1 year, 2 year
Secondary	Squeaking sounds	Number of patients with squeaking Sounds	6 months, 1 year, 2 year
Secondary	Dislocation	Dislocation at different follow-up visits	6 months, 1 year, 2 year