OsteoarthritisBHRNCT01427361
Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Science Centers
London, Ontario, N6G 1G9
Sr. Michaels Hospital
Toronto, Ontario, M5C 1R6
About this study
Official title: Prospective, Multi- Site, Clinical Study of Clinical Outcomes Following Hip Resurfacing Using VISIONAIRE Femoral Alignment Guide
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.
Read the 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.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Surgical and device related adverse events or revision
Measured: 6 week and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427361
- Sponsor's protocol ID
- US-CR-135
- Acronym
- BHR
- Status last verified
- Mar 2018
- First submitted
- 6 Aug 2010
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi- Site, Clinical Study of Clinical Outcomes Following Hip Resurfacing Using VISIONAIRE Femoral Alignment Guide
- ClinicalTrials.gov ID
- NCT01427361
- Acronym / sponsor ID
- BHR / US-CR-135
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 week and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.