G7 Acetabular System vs. Exceed ABT Acetabular System in THA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Osteoarthritis Arthritis Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hip implant1

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.

Group Type EXPERIMENTAL

G7

Intervention Type 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 implant2

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).

Group Type EXPERIMENTAL

Exceed ABT

Intervention Type 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).

Interventions

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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.

Intervention Type DEVICE

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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No