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Completed

NCT Number: NCT02096198

Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement

This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the COC total hip replacement system)

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Key information

Conditions

Non-inflammatory Degenerative Joint Disease Arthritis Avascular Necrosis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Traumatic Osteoarthritis of Hip Rheumatic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sacramento, California, United States

Loading trial locations.

About this study

Up to five (5) sites will participate. These sites participated in the IDE study and will continue subject follow-up.

Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit.

If a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who were previously enrolled in the COC 36 IDE study;
  • 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

  • In the opinion of the Investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations.
  • Any component of the primary total hip was previously revised.

Treatment and study plan

Primary outcomes

  1. Device survivorship at 10-years post-operatively

    Time frame: 10-years post-operatively

    Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.

Secondary outcomes

  1. Harris Hip scores

    Time frame: Harris Hip score means and Harris Hip sub-score means will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)

    The Harris Hip score consists of five sub-scales: Pain, Function, Activities Deformity and Range of motion. The instrument is designed for completion by a clinician.

  2. Subject Hip Outcomes

    Time frame: Subject Hip Outcomes will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)

    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 relate to study subject function, pain, need for pain meds, satisfaction and their status (i.e., better, same or worse).

    The percent of subjects who answer 'Yes' or 'Better' on each respective question will be reported.

  3. Radiographic

    Time frame: At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)

    At 5 to 7 years, at Minimum 8-years and at minimum 10-years, secondary radiographic outcome measures will include high quality antero-posterior and lateral radiographs of the operative hip, which will be obtained during the same postoperative follow-up intervals as for the clinical evaluations. At the first "enrollment" visit (5-7 years), an additional Cross-Table Lateral films will be collected to permit assessment of cup positioning.

    Radiographic views will include:

    • AP Pelvis
    • AP femur
    • Lauenstein Lateral
    • Cross-Table Lateral (only at the first visit at 5-7 years)

    As a single composite radiographic outcome, the percent of subjects with radiolucencies greater than 2 mm in any zone, 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.

  4. Adverse Events

    Time frame: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)

    Subjects who consent to participate in this trial have already had their index surgery for implantation of the study hip; however, potential adverse events may still occur and will be captured at each follow-up visit.

  5. Device survivorship

    Time frame: 5-years, 6-years, 7-years, 8-years, and 9-years

    Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at years 5 through 9 post-operatively

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects

Acronym: COC36mmPAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2014
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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