Clinical trial NCT02340390: G7 Acetabular System vs. Exceed ABT Acetabular System in THA
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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Arthritis
Rheumatoid Arthritis
Keywords: G7 Acetabular System
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the safety and effectiveness of patients (Harris Hip Score)
timeFrame: 1 year
Secondary outcomes:
measure: Gruen zone analysis
timeFrame: Immediate post-op, 6 months, 1 year, 2 year
measure: Loosening on its implant
timeFrame: Immediate post-op, 6 months, 1 year, 2 year
measure: Squeaking sounds
timeFrame: 6 months, 1 year, 2 year
measure: Dislocation
timeFrame: 6 months, 1 year, 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Hospital
Study officials:
affiliation: Seoul Nat'l Univ. Hospital
name: Jung-Joon Yoo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee Uni. Hospital at Gangdong
name: Kee-Hyung Rhyu, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Seung-Jae Lim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Uni. Anam Hospital
name: Seung-Bum Han, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: