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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00663351
First received: February 28, 2008
Last updated: March 17, 2014
Last verified: March 2014

February 28, 2008
March 17, 2014
December 2004
December 2014   (final data collection date for primary outcome measure)
Number of revisions, radiographic assessment, Harris Hip Score (Hip function and radiographic review) [ Time Frame: [Time frame: 3, 6, 12, 24,36,48,60 months] ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00663351 on ClinicalTrials.gov Archive Site
All adverse events reported through 5 year post-operative. [ Time Frame: Intraoperative through 5 year post-operative ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness Study of the Reflection Ceramic Acetabular System
Post Approval Study: Reflection Ceramic Acetabular System

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

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Device: 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.
    Other Names:
    • Hip Replacement
    • Reflection
    • ceramic-ceramic
  • 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.
    Other Names:
    • Hip replacement
    • Reflection
    • ceramic-ceramic
  • Active Comparator: 1
    Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
    Intervention: Device: Reflection Ceramic-Ceramic Total Hip Replacement
  • Active Comparator: 2
    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.
    Intervention: Device: Reflection FSO V Total Hip Replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
345
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663351
PMA 030022
Not Provided
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Principal Investigator: Scott Corpe, M.D. Medical College of Georgia, Dept of Orthopaedic
Principal Investigator: Joseph Zuckerman, M.D. Hospital of Joint Disease, Orthopaedic Institute
Principal Investigator: Jonathan P Garino, M.D. Presbyterian Medical Center, Dept of Orthopaedic
Principal Investigator: Michael J Grecula, M.D. University of Texas Medical Branch, Dept of Orthopaedic
Principal Investigator: James Howe, M.D. University of Vermont
Principal Investigator: Michael Lynch, M.D. The Memphis Orthopaedic Group, PC
Principal Investigator: Norman E Walter, M.D. Family Orthopaedics
Smith & Nephew, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP