Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

NCT00663351 | Completed Results

• 1 other identifier: PMA 030022
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 7

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.

Conditions

Osteoarthritis

Keywords

Arthritis; Osteoarthritis; Traumatic Arthritis; Degenerative Joint Disease; Avascular Necrosis

Outcome Measures

Primary Outcomes (3)

• Survival of Hip Implant Based on Number of Hips Requiring Revision

  Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)

  Postoperatively through Year 10

• Survival of Hip Implant Based on Time Until Revision Required

  The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)

  Postoperatively through Year 10

• Subject Satisfaction Questionnaire

  A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked "Are you satisfied with hip?" and subjects responded either "yes" or "no".

  Year 6 through Year 10 postoperatively

Study Arms (2)

Reflection Ceramic-Ceramic Hip System (IP)

ACTIVE COMPARATOR

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

Device: Reflection Ceramic-Ceramic Total Hip Replacement

Reflection FSO V (5 hole) (Control)

ACTIVE COMPARATOR

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.

Device: Reflection FSO V Total Hip Replacement

Interventions

Reflection Ceramic-Ceramic Total Hip Replacement 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.

Also known as: Hip Replacement, Reflection, ceramic-ceramic

Reflection Ceramic-Ceramic Hip System (IP)

Reflection FSO V Total Hip Replacement 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.

Also known as: Hip replacement, Reflection, ceramic-poly

Reflection FSO V (5 hole) (Control)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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);

You may not qualify if:

• (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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Medical College of Georgia, Department of Orthopaedics

Augusta, Georgia, 30912, United States

Location

Family Orthopaedics

Flint, Michigan, 48507, United States

Location

Hospital of Joint Disease, Orthopaedic Institute

New York, New York, 10003, United States

Location

Presbyterian Medical Center, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, 19104-2699, United States

Location

The Memphis Orthopaedic Group, PC

Memphis, Tennessee, 38104, United States

Location

University of Texas Medical Branch, Dept of Orthopaedics and Rehab

Galveston, Texas, 77555, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Joint Diseases; Osteonecrosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

There were no limitations or caveats determined during the course of the study.

Results Point of Contact

• Title: Rachael Winter, Director, Global Clinical Operations
• Organization: Smith & Nephew, Inc.

rachael.winter@smith-nephew.com

+44 1482 673475

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: April 22, 2008
• Study Start: December 1, 2004
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 13, 2022
• Results First Posted: October 13, 2022

Record last verified: 2015-03

Locations

US (7)