Safety and Effectiveness Study of the Reflection Ceramic Acetabular System (RCH)

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Reflection FSO V Total Hip Replacement; Device: Reflection Ceramic-Ceramic Total Hip Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663351

PMA 030022

Details and patient eligibility

About

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

Full 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

Enrollment: 456 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Reflection Ceramic-Ceramic Hip System (IP)

Active Comparator group

Description:

Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.

Treatment:

Device: Reflection Ceramic-Ceramic Total Hip Replacement

Reflection FSO V (5 hole) (Control)

Active Comparator group

Description:

Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.

Treatment:

Device: Reflection FSO V Total Hip Replacement