36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

NCT00953719 | Completed Results

• 1 other identifier: COC 36 mm
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner. This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

Hip arthroplasty; Acetabular cup; Ceramic-on-polyethylene

Outcome Measures

Primary Outcomes (1)

• Total Harris Hip Score

  The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).

  At final follow-up visit, 24 months or later, up to 72 months

Secondary Outcomes (7)

• Harris Hip Subscale Score: Pain

  At final follow-up visit, 24 months or later, up to 72 months

• Harris Hip Subscale Score: Function

  At final follow-up visit, 24 months or later, up to 72 months

• Harris Hip Subscale Score: Activities

  At final follow-up visit, 24 months or later, up to 72 months

• Harris Hip Subscale Score: Deformity

  At final follow-up visit, 24 months or later, up to 72 months

• Harris Hip Subscale Score: Range of Motion

  At final follow-up visit, 24 months or later, up to 72 months

Study Arms (2)

36 mm

ACTIVE COMPARATOR

36 mm ceramic head on ceramic acetabular liner

Device: 36 mm ceramic head on a ceramic acetabular liner

28 mm ceramic-on-polyethylene

OTHER

28 mm ceramic-on-polyethylene historical control

Device: 28 mm ceramic head on a polyethylene acetabular liner

Interventions

36 mm ceramic head on a ceramic acetabular liner DEVICE

Total hip replacement with a 36 mm ceramic head on a ceramic liner

Also known as: Delta Ceramax head on a ceramic liner.

36 mm

28 mm ceramic head on a polyethylene acetabular liner DEVICE

Total hip replacement with a 28 mm ceramic head on a polyethylene liner.

Also known as: Delta Ceramax head on a polyethylene liner

28 mm ceramic-on-polyethylene

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia.
• X-ray evaluation confirms the presence of NIDJD
• Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants.
• Individuals 20 to 75 years of age at the time of surgery
• Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study.
• Harris Hip Score of 70 or lower
• Pain at least Moderate

You may not qualify if:

• Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
• Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
• Acute femoral neck fracture.
• Above knee amputation of the contralateral and/or ipsilateral leg.
• Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements.
• Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled.
• Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months.
• Patients with a known allergy to metal (e.g. jewelry).
• Skeletally immature patients (tibial and femoral epiphyses are 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 highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
• Presence of known metastatic or neoplastic disease.
• Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis).
• Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease).
• Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (5)

Unknown Facility

Sacramento, California, 95816, United States

Location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Cardinal Orthopaedic Institute

Columbus, Ohio, 43213, United States

Location

Unknown Facility

Alexandria, Virginia, 22306, United States

Location

Limitations and Caveats

At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study.

Results Point of Contact

• Title: Sam Himden
• Organization: DePuy Orthopaedics, Inc.

shimden@its.jnj.com

574-372-7231

Study Officials

• Joel Politi, MD

  Cardinal Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Douglas Dennis, MD

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: August 6, 2009
• Study Start: April 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2013
• Last Updated: April 10, 2019
• Results First Posted: August 29, 2014

Record last verified: 2019-04

Locations

US (5)