G7 Acetabular System vs. Exceed ABT Acetabular System in THA

NCT02340390 | Completed DMC

• 1 other identifier: ORTHO.CR.GH42
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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

Conditions

Osteoarthritis Arthritis; Rheumatoid Arthritis

Keywords

G7 Acetabular System

Outcome Measures

Primary Outcomes (1)

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

  Harris Hip Score

  1 year

Secondary Outcomes (4)

• Gruen zone analysis

  Immediate post-op, 6 months, 1 year, 2 year

• Loosening on its implant

  Immediate post-op, 6 months, 1 year, 2 year

• Squeaking sounds

  6 months, 1 year, 2 year

• Dislocation

  6 months, 1 year, 2 year

Study Arms (2)

Hip implant1

EXPERIMENTAL

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.

Device: G7

Hip implant2

EXPERIMENTAL

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).

Device: Exceed ABT

Interventions

G7 DEVICE

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.

Hip implant1

Exceed ABT DEVICE

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).

Hip implant2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Kyunghee Univ. Hospital

Seoul, 134-727, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Korea Univ. Hospital

Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Joint Diseases; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jung-Joon Yoo, Ph.D

  Seoul Nat'l Univ. Hospital

  PRINCIPAL INVESTIGATOR

• Kee-Hyung Rhyu, Ph.D

  Kyung Hee Uni. Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

• Seung-Jae Lim, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Seung-Bum Han, Ph.D

  Korea Uni. Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 16, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

KR (3)