Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01427361
First received: August 6, 2010
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

The primary objective of this study is to investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing (BHR) surgery postoperatively after total hip resurfacing using the BHR System.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Multi- Site, Clinical Study of Clinical Outcomes Following Hip Resurfacing Using VISIONAIRE Femoral Alignment Guide

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in BHR surgery postoperatively after total hip resurfacing using the BHR System [ Time Frame: 6 week ] [ Designated as safety issue: Yes ]
    Radiographic evaluation of postoperative femoral stem angle.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 week and 6 month ] [ Designated as safety issue: No ]
    Surgical and device related adverse events or revision


Enrollment: 25
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, multi- site, clinical study of clinical outcomes following hip resurfacing using VISIONAIRE Femoral Alignment Guide. The objective of this study is to evaluate the safety and efficacy of the blocks and to assess alignment of the BHR system when using VISIONAIRE Femoral Alignment Guide. This study will also document any device-related surgical complications or adverse radiographic observations.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The patient population considered for this study is patients requiring total hip resurfacing. The following inclusion and exclusion criteria will be used to identify study candidates.

Criteria

Inclusion Criteria:

  1. Males or females, at least 21 years of age, inclusive, and skeletally mature.
  2. Patient diagnosed with osteoarthritis of the hip requiring primary total hip resurfacing due to:

    • Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
    • Inflammatory arthritis such as rheumatoid arthritis.
  3. Patient is willing to consent to participate in the study
  4. Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
  5. Patient meets medical clearance to have surgery required for this study

Exclusion Criteria:

  1. Patient with infection or sepsis.
  2. Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
  3. Patient is pregnant or plans to become pregnant during the course of the study.
  4. Patient known to have insufficient bone stock to support the BHR device including:

    • Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or severe osteopenia.
    • Subjects with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
    • Subjects with multiple cysts of the femoral head (>1cm) should not receive a BHR.
    • Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
  5. Patient has known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration.
  6. Patient has a known sensitivity to materials in the device.
  7. Patient is immuno-suppressed.
  8. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
  9. Patient has BMI >40.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427361

Locations
Canada, Ontario
London Health Science Centers
London, Ontario, Canada, N6G 1G9
Canada
Sr. Michaels Hospital
Toronto Ontario, Canada, M5C 1R6
Sponsors and Collaborators
Smith & Nephew, Inc.
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01427361     History of Changes
Other Study ID Numbers: US-CR-135
Study First Received: August 6, 2010
Last Updated: September 17, 2012
Health Authority: Canada: University of Western Ontario Ethics Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014