Hallux Valgus and BunionNCT06570590
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
A study testing Minimally invasive lapidus procedure with no arthroscopy and Minimally invasive lapidus procedure with arthroscopy in people with Hallux Valgus and Bunion, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a newer approach. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- Minimally invasive lapidus procedure with no arthroscopy and Minimally invasive lapidus procedure with arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is at least 19 years of age.
- The subject is considered to be skeletally mature.
- The subject is undergoing an isolated 1st TMT, which may or may not include concomitant procedures, such as:
- Soft tissue realignment
- Heel cord lengthening
- Akin osteotomy
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- Lesser toe osteotomies or claw toe correction
- The subject is able to comply with all post-operative evaluations and visits.
- The subject is able to provide informed consent.
- The subject consents to and will receive either arthroscopy or no arthroscopy condition using the PROstep MIS 5mm Chamfer Screw.
Who cannot join
- Patients indicated for TMT fusion for non-hallux valgus procedures.
- Patients with simultaneous fusion of second and third ray.
- Patients indicated for navicular-cuneiform joint performed at the same time.
- The subject has:
- Arthritis in the affected joint
- Severe osteoporosis
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- Neuromuscular impairment
- Prior or current infection in the affected joint
- Charcot foot
- The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt).
- The subject will be undergoing an ankle replacement, any other concomitant fusion(s), or any lesser metatarsal osteotomies in the affected foot or ankle in the same sitting.
- The subject has concomitant injury, which in the opinion of the Investigator, is likely to impair functions for as long as or longer than the recovery from the subject's 1st TMT fusion.
- The subject is deemed morbidly obese (BMI \> 50 kg/m2
- The subject has a major risk factor for non-union (ex. poorly controlled diabetes, current smoker).
- There is radiographic evidence of bone cysts, segmental defects or growth plate fracture around the fusion site that may negatively impact bony fusion. The patient currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.
- The subject is known to be pregnant during the study period.
- The Investigator judges the subject to be unable or unlikely to remain compliant to follow-up due to a physical or mental condition (ex. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.).
- The subject is unable to provide informed consent.
- The subject is unable to communicate with the research team.
- The subject is unable to comply with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Biraj Bora, 604-813-0889, bbora@providencehealth.bc.ca
About this study
Official title: A Prospective Study of the Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities Randomized With Arthroscopy or No Arthroscopy at St. Paul's Hospital in Vancouver, Canada
The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a newer approach. Because it's newer, there is not studies on how patients feel about it directly through patient reported outcomes (PROMs), which involve patients filling out questionnaires. Previous studies have looked at information that could be gathered from radiographs. This study looks specifically at how well bones heal after the MIS procedure and how patients feel about it based on their recorded responses in PROMs. The Lapidus procedure involves a step where the surgeon checks for the amount of cartilage removal, which can be done by inserting a mini camera into the joint (arthroscopically) or through a small incision for visual inspection. These two methods of checking cartilage removal are the two treatment groups for this study that patients are randomly assigned to.
The main goals of the study are as follows:
- To determine healing in minimally invasive Lapidus. Evaluated by bones fusing together at 12 weeks post-operation.
- To determine patient reported outcomes following Lapidus procedures
- To determine the relationship between patient-reported outcomes and percent bone healing.
- To assess the nonunion (bone not fusing together) rate and re-operation rate following Lapidus procedures
- To assess the correction achieved on radiographic and standing CT measurements.
- To compare radiographic and Standing CT assessment of hallux valgus deformity and correction after surgery.
- Conditions
- Hallux Valgus and Bunion
- Being tested
- Minimally invasive lapidus procedure with no arthroscopy, Minimally invasive lapidus procedure with arthroscopy
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive lapidus procedure with no arthroscopyProcedure or surgery
Also called No arthroscopy, MIS no arthroscopy, mini arthrotomy
The two procedures, with and without arthroscopy, only differ by the method of assessing cartilage removal. Cartilage removal will be assessed arthroscopically in the procedure with arthroscopy. In the procedure without arthroscopy, cartilage removal will be assessed via direct visualization through a mini arthrotomy procedure. After use of the cartilage burr the surgeon will make a small dorsal portal and use this opening to ensure that the cartilage is removed and all debris removed. The incision will be 2 cm long and centered over the dorsal medial aspect of the joint.
Minimally invasive lapidus procedure with arthroscopyProcedure or surgery
Also called With scope
After removal of the cartilage with the cartilage burr, a 3.0 arthroscope will be inserted to inspect the joint for all cartilage removal. Any residual cartilage pieces will be removed to ensure complete cartilage debridement from the subchondral bone and fragments removed from the joint.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopy | Active comparator | Using arthroscopy in minimally invasive lapidus procedure is the current standard of care. However a new screw is used (PROstep MIS 5mm Chamfer Screw). The new hardware is expected to be substantially equivalent to standard of care. Receives: Procedure: Minimally invasive lapidus procedure with arthroscopy |
| No Arthroscopy | Experimental | Non-Arthroscopic Mini Arthrotomy Procedure (research-specific): Surgical procedure between the two treatment groups are equivalent except at the step of checking cartilage removal. After use of the cartilage burr the surgeon will make a small dorsal portal and use this to ensure that the cartilage is removed and all debris removed. The incision will be 2 cm long and centered over the dorsal medial aspect of the joint. The Principal Investigator wants to know if the mini arthrotomy procedure is as effective as the control because this procedure is faster and easier to perform. Receives: Procedure: Minimally invasive lapidus procedure with no arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Bone Fusion
Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans
Measured: At 12 weeks post-operation
Secondary outcomes (4)
Secondary: Questionnaires-Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
Patient reported outcomes as measured by MODEMS (includes AOS and SF-36) compared to baseline questionnaire.
Measured: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Questionnaires-Foot and Ankle Ability Measure (FAAM)
Patient reported outcomes as measured by FAAM compared to baseline questionnaire.
Measured: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Questionnaires-Pain Catastrophizing Scale (PCS)
Patient reported outcomes as measured by PCS compared to baseline questionnaire.
Measured: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Re-operation and complication rates
Reoperations and complications will be recorded
Measured: At any point during enrolment up to 52 weeks post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus and BunionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- 58 patients total. 29 will be randomly assigned to arthroscopy group, 29 will be randomly assigned to mini open group.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Alastair Younger, University of British Columbia
- Investigators
- Alastair Younger, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570590
- Sponsor's protocol ID
- H23-03971
- Status last verified
- Aug 2024
- First submitted
- 14 May 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities Randomized With Arthroscopy or No Arthroscopy at St. Paul's Hospital in Vancouver, Canada
- ClinicalTrials.gov ID
- NCT06570590
- Acronym / sponsor ID
- H23-03971
- Conditions
- Hallux Valgus and Bunion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- 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 Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a newer approach. Because it's newer, there is not studies on how patients feel about it directly through patient reported outcomes (PROMs), which involve patients filling out questionnaires. Previous studies have looked at information that could be gathered from radiographs. This study looks specifically at how well bones heal after the MIS procedure and how patients feel about it based on their recorded responses in PROMs. The Lapidus procedure involves a step where the surgeon checks for the amount of cartilage removal, which can be done by inserting a mini camera into the joint (arthroscopically) or through a small incision for visual inspection. These two methods of checking cartilage removal are the two treatment groups for this study that patients are randomly assigned to.
The main goals of the study are as follows:
- To determine healing in minimally invasive Lapidus. Evaluated by bones fusing together at 12 weeks post-operation.
- To determine patient reported outcomes following Lapidus procedures
- To determine the relationship between patient-reported outcomes and percent bone healing.
- To assess the nonunion (bone not fusing together) rate and re-operation rate following Lapidus procedures
- To assess the correction achieved on radiographic and standing CT measurements.
- To compare radiographic and Standing CT assessment of hallux valgus deformity and correction after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 58 patients total. 29 will be randomly assigned to arthroscopy group, 29 will be randomly assigned to mini open group.
| Arm | Type | Receives |
|---|---|---|
| Arthroscopy | Active comparator | Procedure: Minimally invasive lapidus procedure with arthroscopyUsing arthroscopy in minimally invasive lapidus procedure is the current standard of care. However a new screw is used (PROstep MIS 5mm Chamfer Screw). The new hardware is expected to be substantially equivalent to standard of care. |
| No Arthroscopy | Experimental | Procedure: Minimally invasive lapidus procedure with no arthroscopyNon-Arthroscopic Mini Arthrotomy Procedure (research-specific): Surgical procedure between the two treatment groups are equivalent except at the step of checking cartilage removal. After use of the cartilage burr the surgeon will make a small dorsal portal and use this to ensure that the cartilage is removed and all debris removed. The incision will be 2 cm long and centered over the dorsal medial aspect of the joint. The Principal Investigator wants to know if the mini arthrotomy procedure is as effective as the control because this procedure is faster and easier to perform. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject is at least 19 years of age.
- The subject is considered to be skeletally mature.
- The subject is undergoing an isolated 1st TMT, which may or may not include concomitant procedures, such as:
- The subject is able to comply with all post-operative evaluations and visits.
- The subject is able to provide informed consent.
Key exclusion criteria (20 listed)
- Patients indicated for TMT fusion for non-hallux valgus procedures.
- Patients with simultaneous fusion of second and third ray.
- Patients indicated for navicular-cuneiform joint performed at the same time.
- The subject has:
- The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt).
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 |
|---|---|---|
| Minimally invasive lapidus procedure with no arthroscopyAlso: No arthroscopy, MIS no arthroscopy, mini arthrotomyThe two procedures, with and without arthroscopy, only differ by the method of assessing cartilage removal. Cartilage removal will be assessed arthroscopically in the procedure with arthroscopy. In the procedure without arthroscopy, cartilage removal will be assessed via direct visualization through a mini arthrotomy procedure. After use of the cartilage burr the surgeon will make a small dorsal portal and use this opening to ensure that the cartilage is removed and all debris removed. The incision will be 2 cm long and centered over the dorsal medial aspect of the joint. | Procedure or surgery | No Arthroscopy |
| Minimally invasive lapidus procedure with arthroscopyAlso: With scopeAfter removal of the cartilage with the cartilage burr, a 3.0 arthroscope will be inserted to inspect the joint for all cartilage removal. Any residual cartilage pieces will be removed to ensure complete cartilage debridement from the subchondral bone and fragments removed from the joint. | Procedure or surgery | Arthroscopy |
Primary outcome
Primary: Bone Fusion
Time frame: At 12 weeks post-operation
Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans
4 secondary outcomes
Secondary: Questionnaires-Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS)
Time frame: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Questionnaires-Foot and Ankle Ability Measure (FAAM)
Time frame: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Questionnaires-Pain Catastrophizing Scale (PCS)
Time frame: Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)
Secondary: Re-operation and complication rates
Time frame: At any point during enrolment up to 52 weeks post-operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alastair Younger principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive lapidus procedure with no arthroscopy and Minimally invasive lapidus procedure with arthroscopy in people with Hallux Valgus and Bunion, run by St. Paul's Hospital, Canada 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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 26 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biraj Bora (604-813-0889, bbora@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: Bone Fusion (time frame: At 12 weeks post-operation). 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 26 Aug 2024.