Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

NCT ID: NCT00663351

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2014-12-31

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

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reflection Ceramic-Ceramic Hip System (IP)

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

Group Type: ACTIVE_COMPARATOR

Reflection Ceramic-Ceramic Total Hip Replacement

Intervention Type: DEVICE

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Reflection FSO V (5 hole) (Control)

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.

Group Type: ACTIVE_COMPARATOR

Reflection FSO V Total Hip Replacement

Intervention Type: DEVICE

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Interventions

Reflection Ceramic-Ceramic Total Hip Replacement

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Intervention Type: DEVICE

Reflection FSO V Total Hip Replacement

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Intervention Type: DEVICE

Other Intervention Names

Hip Replacement; Reflection; ceramic-ceramic; Hip replacement; Reflection; ceramic-poly

Eligibility 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);

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Corpe, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Georgia, Dept of Orthopaedic

Joseph Zuckerman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital of Joint Disease, Orthopaedic Institute

Jonathan P Garino, M.D.

Role: PRINCIPAL_INVESTIGATOR

Presbyterian Medical Center, Dept of Orthopaedic

Michael J Grecula, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Dept of Orthopaedic

James Howe, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Michael Lynch, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Memphis Orthopaedic Group, PC

Norman E Walter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Family Orthopaedics

Locations

Medical College of Georgia, Department of Orthopaedics

Augusta, Georgia, United States

Family Orthopaedics

Flint, Michigan, United States

Hospital of Joint Disease, Orthopaedic Institute

New York, New York, United States

Presbyterian Medical Center, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, United States

The Memphis Orthopaedic Group, PC

Memphis, Tennessee, United States

University of Texas Medical Branch, Dept of Orthopaedics and Rehab

Galveston, Texas, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

Countries

United States

Other Identifiers

PMA 030022

Identifier Type: -

Identifier Source: org_study_id