Clinical trial NCT00663351: Safety and Effectiveness Study of the Reflection Ceramic Acetabular System
Official title: Post Approval Study: Reflection Ceramic Acetabular System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Arthritis
Osteoarthritis
Traumatic Arthritis
Degenerative Joint Disease
Avascular Necrosis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 456
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.

Detailed description: This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients previously enrolled in the IDE study will be evaluated annually through five (5) year follow-up. In addition, all patients enrolled in the original study cohorts as well as the continued access patients will be sent a letter questionnaire annually at the 6-10 year postoperative time point to assess the patient's general well-being and if the study components are still in place

Eligibility criteria: Criteria

Inclusion Criteria:

(Patient must meet all of the following characteristics to be enrolled in the study):

* Males and females, 21 to 80 years of age, inclusive;
* Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
* The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
* The patient will be available for follow-up through at least two years postoperative;
* The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
* The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement);
* The patient meets none of the exclusion criteria.

Exclusion Criteria:

(Patient with any of the following characteristics must be excluded from the study):

* Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (\> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
* Patients with active localized or systemic infection;
* Patients who have not reached full skeletal maturity;
* Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
* The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
* Immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis).
* Pregnancy.
* Patients with known sensitivity to materials in the device.

Primary outcomes:
measure: Survival of Hip Implant Based on Number of Hips Requiring Revision
timeFrame: Postoperatively through Year 10
measure: Survival of Hip Implant Based on Time Until Revision Required
timeFrame: Postoperatively through Year 10
measure: Subject Satisfaction Questionnaire
timeFrame: Year 6 through Year 10 postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia, Department of Orthopaedics
state: Georgia
city: Flint
country: United States
facility: Family Orthopaedics
state: Michigan
city: New York
country: United States
facility: Hospital of Joint Disease, Orthopaedic Institute
state: New York
city: Philadelphia
country: United States
facility: Presbyterian Medical Center, Department of Orthopaedic Surgery
state: Pennsylvania
city: Memphis
country: United States
facility: The Memphis Orthopaedic Group, PC
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch, Dept of Orthopaedics and Rehab
state: Texas
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
affiliation: Medical College of Georgia, Dept of Orthopaedic
name: Scott Corpe, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Joint Disease, Orthopaedic Institute
name: Joseph Zuckerman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Presbyterian Medical Center, Dept of Orthopaedic
name: Jonathan P Garino, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch, Dept of Orthopaedic
name: Michael J Grecula, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: James Howe, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Memphis Orthopaedic Group, PC
name: Michael Lynch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Orthopaedics
name: Norman E Walter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: