Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)

Osteoarthritis Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02096211
• Other study ID #: 12017
• Status: Active, not recruiting
• Start date: June 1, 2014
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Joint Diseases
• Necrosis
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Osteoarthritis, Hip
• Post-Traumatic Osteoarthritis of Hip

Intervention

Device:
• COC 36mm
Total Hip Replacement with COC 36mm Acetabular Cup System

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Queens University - Kingston General Hospital	Kingston	Quebec
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	McGill University - Jewish General Hospital	Montreal	Quebec
United States	New England Baptist Hospital	Boston	Massachusetts
United States	TUFTS - New England Medical Center	Boston	Massachusetts
United States	Orthopedic One	Columbus	Ohio
United States	Colorado Joint Replacement	Denver	Colorado
United States	Samuel Wellman, MD / Duke University Medical Center	Durham	North Carolina
United States	Arthroplasty Foundation	Louisville	Kentucky
United States	UPenn	Philadelphia	Pennsylvania
United States	Joint Surgeons of Sacremento	Sacramento	California
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Survivorship at 5-years post-operatively	Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 5 years post-operatively.	5 years post-operatively
Secondary	Device Survivorship	Device survivorship will be estimated at each year post-operatively using the Kaplan-Meier Survivorship Analysis	1-year, 2-years, 3-years, and 4-years
Secondary	Harris Hip Scores	The Harris Hip score consists of five subscales: Pain, Function, Activities, Deformity and Range of motion. This validated outcomes instrument is designed for completion by a clinician.	Harris Hip Score means and Harris Hip Sub-score means will be estimated at 6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825-2555 days)
Secondary	Subject Hip Outcomes (Clinic)	Subject Hip Outcomes (Clinic) will be estimated at each year post-operatively. Subject Hip Outcomes is a standardized instrument for use as a measure of health outcome that is designed for completion by the study subject. This hips outcomes self-assessment includes five (5) questions about subject satisfaction and hip function. The 5 questions subject's will answer regard their function, pain, need for pain meds, satisfaction and status (i.e., better, same, worse).; The percent of subjects who answer 'Yes' or 'Better' on each respective question will be reported.	Subject Hip Outcomes will be estimated at 6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)
Secondary	Radiographs	High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. At the first post-operative visit (6-Weeks), an additional Cross-Table Lateral film will be collected to permit assessment of the cup positioning.; Radiographic views: AP; AP femur view is required only when the distal end of the femur is not visible on the AP-Pelvis view); Lateral; Cross-Table Lateral (Only at 6-Week post-op); As a single composite radiographic outcome, the percent of subjects with radiolucencies greater than 2 mm, acetabular cup migration greater than 4 mm, change in cup inclination greater than 4 degrees or osteolysis at the time of last radiographic assessment will be reported.	6-Weeks, (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)
Secondary	Adverse Events	Adverse Events must be reported for all Subjects and will be reported by category (intraoperative, postoperative-operative site, systemic, and overall) at all study visit intervals.	6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)