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

NCT01427361 | Completed

• 1 other identifier: US-CR-135
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (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

  Radiographic evaluation of postoperative femoral stem angle.

  6 week

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  6 week and 6 month

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Males or females, at least 21 years of age, inclusive, and skeletally mature.
• 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.
• Patient is willing to consent to participate in the study
• 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.
• Patient meets medical clearance to have surgery required for this study

You may not qualify if:

• Patient with infection or sepsis.
• Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
• Patient is pregnant or plans to become pregnant during the course of the study.
• 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.
• 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.
• Patient has a known sensitivity to materials in the device.
• Patient is immuno-suppressed.
• Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
• Patient has BMI \>40.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

London Health Science Centers

London, Ontario, N6G 1G9, Canada

Location

Sr. Michaels Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: September 1, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

CA (2)