Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570590
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-14
Brief Title:
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study of the Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities Randomized With Arthroscopy or No Arthroscopy at St Pauls Hospital in Vancouver Canada
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Because its 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None