Hallux ValgusHallux valgusNCT01791634
Prospective, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle
A study testing proximal chevron osteotomy and proximal open wedge osteotomy with LPS system in people with Hallux Valgus, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus the proximal chevron osteotomy? Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- proximal chevron osteotomy and proximal open wedge osteotomy with LPS system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Jun 2012
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age (> 16 years of age) moderate to severe hallux valgus angle [HVA] of >30º with increased intermetatarsal angles [IMA] of >13º
- persistent incapacitating symptoms despite non-operative treatment (shoe wear modification, orthoses, non-steroidal anti-inflammatory drugs and restricted activity)
Who cannot join
- degenerative arthritis of 1st metatarsophalangeal (MTP) joint
- neuropathic patients
- diabetes mellitus
- peripheral vascular disease
- previous 1st metatarsal, hallux or MTP joint surgery
- active or recent foot/toe infection
- currently participation in a another clinical trial
- Worker's Compensation Board patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle
Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus the proximal chevron osteotomy?
Read the detailed description
Is there a difference in radiologic outcomes of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in surgical times or surgeon procedure preference in the treatment of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in complication rates of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy?
- Conditions
- Hallux Valgus
- Being tested
- proximal chevron osteotomy, proximal open wedge osteotomy with LPS system
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal chevron osteotomyProcedure or surgery
proximal open wedge osteotomy with LPS systemProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| proximal open wedge osteotomy with LPS system | Experimental | Proximal open wedge osteotomy with Low profile plate and screws Receives: Procedure: proximal open wedge osteotomy with LPS system |
| proximal wedge osteotomy | Active comparator | Proximal wedge osteotomy procedure Receives: Procedure: proximal chevron osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2007
- Primary completionJan 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Principal investigator, Mark Glazebrook, Nova Scotia Health Authority
- Investigators
- Dr Mark A Glazebrook, MSc PhD Dip Sports Med MD,FRCS, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791634
- Sponsor's protocol ID
- Version1 Jan 4 2007
- Acronym
- Hallux valgus
- Status last verified
- Jul 2018
- First submitted
- 11 Feb 2013
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle
- ClinicalTrials.gov ID
- NCT01791634
- Acronym / sponsor ID
- Hallux valgus / Version1 Jan 4 2007
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- Apr 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Feb 2013 (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.
Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus the proximal chevron osteotomy?
Detailed description
Is there a difference in radiologic outcomes of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in surgical times or surgeon procedure preference in the treatment of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in complication rates of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal open wedge osteotomy with LPS system | Experimental | Procedure: proximal open wedge osteotomy with LPS systemProximal open wedge osteotomy with Low profile plate and screws |
| proximal wedge osteotomy | Active comparator | Procedure: proximal chevron osteotomyProximal wedge osteotomy procedure |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age (> 16 years of age) moderate to severe hallux valgus angle [HVA] of >30º with increased intermetatarsal angles [IMA] of >13º
- persistent incapacitating symptoms despite non-operative treatment (shoe wear modification, orthoses, non-steroidal anti-inflammatory drugs and restricted activity)
Key exclusion criteria (8 listed)
- degenerative arthritis of 1st metatarsophalangeal (MTP) joint
- neuropathic patients
- diabetes mellitus
- peripheral vascular disease
- previous 1st metatarsal, hallux or MTP joint surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proximal chevron osteotomy | Procedure or surgery | proximal wedge osteotomy |
| proximal open wedge osteotomy with LPS system | Procedure or surgery | proximal open wedge osteotomy with LPS system |
Primary outcome
Short Form 36
Time frame: 1 year
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 19 Jul 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.
Dr Mark A Glazebrook, MSc PhD Dip Sports Med MD,FRCS principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proximal chevron osteotomy and proximal open wedge osteotomy with LPS system in people with Hallux Valgus, run by Nova Scotia Health Authority at 1 site 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 2 inclusion and 8 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Short Form 36 (time frame: 1 year). 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 19 Jul 2018.