Post Approval Study: NOVATION Ceramic Articulation Hip System

NCT00715143 | Terminated

• 1 other identifier: CR05-005
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").

Conditions

Total Hip Replacement (Non-inflammatory)

Keywords

hip; replacement; ceramic; orthopaedic; joint; degenerative; non-inflammatory; osteoarthritis; avascular necrosis; congenital hip dysplasia; traumatic arthritis

Outcome Measures

Primary Outcomes (3)

• Radiographic evaluation of radiolucency

  Radiographic analysis

  Immediately post operation, 6 weeks, 6 months, annually 1-5 years

• Survivorship of device components

  Device Survivorship

  Immediately post operation, 6 weeks, 6 months, annually 1-5 years

• Harris Hip Score

  Physician assessed outcome

  Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Study Arms (1)

All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System

OTHER

All subjects will receive the Novation Ceramic on Ceramic Articulating Hip System.

Device: Novation Ceramic

Interventions

Novation Ceramic DEVICE

This treatment is the study device (which will be compared to a similar historic control device)

Also known as: Novation

All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing primary hip surgery for symptomatic Non-inflammatory Degenerative Joint Disease (NIDJD). Composite diagnosis of NIDJD includes osteo/ degenerative arthritis, traumatic arthritis, congenital hip dysplasia and avascular necrosis.
• Patient is 21 years of age or older at the time of surgery.
• Patient is skeletally mature (tibial and femoral epiphyses are closed).
• Patient is willing and able to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period; including 5 years of in-clinic visits followed by 5 years of mail-in questionnaire follow-up.
• Patient is female and of childbearing age, for whom a negative urine pregnancy test is obtained immediately prior to surgery.

You may not qualify if:

• Patient agrees to participate and sign the Informed Consent Form.
• Patient will be less than 21 years old at the time of surgery.
• Patient is skeletally immature.
• Patient presents with inflammatory degenerative joint disease.
• Patient has evidence of active infection, but not including asymptomatic urinary tract infection (UTI) if treated with antibiotics preoperatively.
• Patient is female and of child bearing age and is pregnant or whose pregnancy status is unknown.
• Patient has neurological or musculoskeletal disease that may adversely affect gait or weight bearing.
• Patient has known presence of active metastatic or neoplastic disease (active is defined as within the past 5 years. Does not include basal cell carcinoma in cases when a subject with this diagnosis has undergone radical excision of the lesion, has pathological proof that the lesion has clean and clear peripheral and deep borders, and the location of the lesion is not near the operative hip or on the affected extremity).
• Patient has poor bone quality (e.g., osteoporosis) where, in the investigator's opinion, there is inadequate bone to support the implant(s).
• Patient has the presence of a previous prosthetic hip replacement device (any type, including THA, surface replacement arthroplasty, endoprosthesis, etc.) in the operative hip joint.
• Patient is known to have presence of a highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
• Patient is a prisoner.
• Patient is obese where obesity is defined as a Body Mass Index (BMI) greater than 35. BMI = Weight (lbs.) ÷ Height (in.)2 x 703
• Patient has neuropathic joints.
• Patient has known allergies to the implant materials.

Sponsors & Collaborators

• Exactech: lead

Study Sites (5)

Shrock Orthopedic Research

Fort Lauderdale, Florida, 33316, United States

Location

Resurgens Orthopaedics

Cumming, Georgia, 30041, United States

Location

Fallon Clinic

Worcester, Massachusetts, 01608, United States

Location

Tulsa Bone & Joint Associates

Tulsa, Oklahoma, 74146, United States

Location

Hampton Roads Orthopaedics & Sports Medicine

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2008
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: August 31, 2022

Record last verified: 2015-02

Locations

US (5)