An interventional study of Minimally invasive lapidus procedure with no arthroscopy and Minimally invasive lapidus procedure with arthroscopy in Hallux Valgus and Bunion, sponsored by St. Paul's Hospital, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by St. Paul's Hospital, Canada · Not applicable, Interventional, and Treatment
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:
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 58 is close to the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →St. Paul's Hospital, Canada is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The subject is undergoing an isolated 1st TMT, which may or may not include concomitant procedures, such as:
Exclusion Criteria:
The subject has:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Minimally invasive lapidus procedure with arthroscopy
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.
Procedure: Minimally invasive lapidus procedure with no arthroscopy
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.
Also known as: No arthroscopy, MIS no arthroscopy, mini arthrotomy
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.
Also known as: With scope
Primary: Bone Fusion
Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans
Time frame: At 12 weeks post-operation
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.
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)
Patient reported outcomes as measured by FAAM compared to baseline questionnaire.
Time frame: 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.
Time frame: 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
Time frame: At any point during enrolment up to 52 weeks post-operation.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Oct 2026, 24 months later.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 24 months is close to that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Paul's Hospital, Canada