Clinical trial NCT02096211: Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
Official title: 36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Post-Traumatic Osteoarthritis of Hip
Keywords: Total hip replacement
Total hip arthroplasty
Hip joint replacement
Hip prosthesis replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 172
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.

Detailed description: Up to 10 (up to 5 original IDE + 5 new sites)

A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days).

Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events.

In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.

Eligibility criteria: Inclusion Criteria:

* Males and females between 21 - 75 at the time of surgery.
* Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
* Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
* Individuals who are willing and able to provide informed patient consent for participation in the study;
* Individuals who are willing and able to return for follow-up as specified by the study protocol; and
* Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.

Exclusion Criteria:

* Skeletally immature patients (tibial and femoral epiphyses not closed)
* Evidence of active infections that may spread to other areas of the body (e.g.,osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.)
* The presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
* Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
* Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
* Any condition that may interfere with postoperative recovery (e.g., Paget's disease, Charcot's disease)
* Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)
* Poor skin coverage around the hip joint
* Use in patients with known allergies to the implant materials
* Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones.
* Inflammatory degenerative joint disease (like rheumatoid arthritis)
* Subject has participated in an IDE/IND clinical investigation, other than the COC28/COC36 IDE or PAS for their contralateral hip, with an investigational product in the last three months.
* Subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims.
* Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to comply with protocol procedures and/or subject-completed questionnaires.
* The Subject is a woman who is pregnant or lactating.
* The Subject has a medical condition with less than 2 years of life expectancy.

Primary outcomes:
measure: Post-Operative 5-Year Device Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: Kaplan Meier Device Survivorship at Years 1 Through 6
timeFrame: Years 1 through 6 post-operatively
measure: Annual Total Harris Hip Score
timeFrame: Annually through 5 years
measure: Annual Harris Hip Pain Sub Score
timeFrame: Annually through 5 years
measure: Annual Harris Hip Function and Activity Score
timeFrame: Annually through 5 years
measure: Acetabular Cup Version - Annual Measurements
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Acetabular Cup Inclination
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Acetabular Cup Migration
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Heterotopic Ossification
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Acetabular Radiolucent Lines
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Acetabular Osteolysis
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Acetabular Sclerotic Lines
timeFrame: Measured from x-rays taken annually, years 1 though 5
measure: Femoral Stem Position
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Stem Tilt
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Stem Subsidence
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Stem Heterotopic Ossification
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Radiolucent Lines
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Osteolysis
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Stem Sclerotic Lines
timeFrame: Measured from x-rays taken annually, years 1 through 5
measure: Femoral Stem Calcar Resorption
timeFrame: Measure from x-rays taken annually, years 1 through 5
measure: Femoral Stem Calcar Fracture
timeFrame: Measured from x-rays taken annually, years 1 through 5
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Joint Surgeons of Sacremento
state: California
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Louisville
country: United States
facility: Arthroplasty Foundation
state: Kentucky
city: Boston
country: United States
facility: TUFTS - New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Durham
country: United States
facility: Samuel Wellman, MD / Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Orthopedic One
state: Ohio
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Kingston
country: Canada
facility: Queens University - Kingston General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Jewish General Hospital
state: Quebec
Study officials:
affiliation: DePuy Orthopaedics
name: Terrence D Whalen, BS, DC
role: STUDY_DIRECTOR
References: