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

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ClinicalTrials.gov Identifier: NCT01427361
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
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 or disease
Osteoarthritis

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.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective, Multi- Site, Clinical Study of Clinical Outcomes Following Hip Resurfacing Using VISIONAIRE Femoral Alignment Guide
Study Start Date : October 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]
    Radiographic evaluation of postoperative femoral stem angle.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 week and 6 month ]
    Surgical and device related adverse events or revision



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427361


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

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01427361     History of Changes
Other Study ID Numbers: US-CR-135
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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