Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520917
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Accuracy and Safety of a Locator-Positioner Guide Device to Assist in Temporomandibular Joint Arthroscopy
Status:
COMPLETED
Status Verified Date:
2018-04
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:
TMJ-LOPO
Brief Summary:
The goal of this clinical trial is to evaluate a guide device locator-positioner LOPO guide device that is intended to aid the surgeon in temporomandibular joint TMJ arthroscopy The aim of the device is to help the surgeon introduce the arthroscope and working cannula into the TMJ space The trial evaluates the accuracy and safety of the device
The main questions it aims to answer are
Does the LOPO guide device increase the accuracy of inserting the arthroscope and working cannula into the temporomandibular joint
Does the number of attempts to correctly place the working cannula relative to the arthroscope decrease
Does the overall time of surgery decrease when using the LOPO device
Does the device pose new surgical risks to temporomandibular joint arthroscopy
The LOPO device was tried on anatomical models and proved to be very accurate The present study recruits up to 10 patients to participate in this experiment IRB approval and Ministry of Health approval have been given for conducting the clinical trial in 10 patients
Participants will
Have a diagnosis of temporomandibular closed lock based on clinical and imaging findings
Undergo temporomandibular joint arthroscopy with the aid of the LOPO device
Visit the clinic for routine follow-up visits after roughly 1 week 3 weeks 2 months and 6 months postoperatively and at each visit be evaluated for maximal mouth opening and severity of pain on a 1-10 VAS
The main questions it aims to answer are
Does the LOPO guide device increase the accuracy of inserting the arthroscope and working cannula into the temporomandibular joint
Does the number of attempts to correctly place the working cannula relative to the arthroscope decrease
Does the overall time of surgery decrease when using the LOPO device
Does the device pose new surgical risks to temporomandibular joint arthroscopy
The LOPO device was tried on anatomical models and proved to be very accurate The present study recruits up to 10 patients to participate in this experiment IRB approval and Ministry of Health approval have been given for conducting the clinical trial in 10 patients
Participants will
Have a diagnosis of temporomandibular closed lock based on clinical and imaging findings
Undergo temporomandibular joint arthroscopy with the aid of the LOPO device
Visit the clinic for routine follow-up visits after roughly 1 week 3 weeks 2 months and 6 months postoperatively and at each visit be evaluated for maximal mouth opening and severity of pain on a 1-10 VAS
Detailed Description:
Temporomandibular joint arthroscopy allows for direct visualization and access to the joint enabling surgeons the ability to diagnose and perform a wide range of procedures Arthroscopic surgery mandates the insertion of at least two portals into the joint cavity The first is the arthroscope and is usually made through a lateral approach into the posterior recess of the superior joint space Generally this is an easy puncture as the glenoid fossa is easily palpated and the target point is just deep to the skin and joint capsule The second puncture is intended to incorporate the working cannula through which instruments are introduced into the joint cavity and is generally targeted to the anterior recess of the superior joint space For the second or working cannula to be readily visualized by the arthroscope and functional skin puncture site angulation of insertion and insertion depth must be accurate and precise The site and technique of the second puncture are dictated by the anatomy and volume of the anterior recess of the superior joint space which has great variability between individuals and joint conditions The target point is the juncture between the anterior aspect of the anterior slope of the articular eminence and the continuation of the zygoma which is generally not palpable To overcome this difficulty the triangulation technique was adapted for the temporomandibular joint by pioneer arthroscopists such as K Murakami and J P McCain The rationale behind using it was to facilitate easier and more predictable entry of the second portal to avoid unnecessary scuffing or damaging of the joint surfaces It enables a repeatable safe and strategic insertion and placement for the second cannula that provides access to different areas in the joint while being fully visualized by the arthroscope
Adherence to the triangulation principles is essential for achieving a successful placement of the second or working cannula However it takes a considerable amount of time to become proficient in this technique Furthermore maintaining the optimal spatial alignment of the working cannula with the arthroscope throughout the surgery necessitates additional practice experience and synchronized collaboration between the surgeon and assistant
The main author developed a Locator-Positioner LOPO guide device to assist the surgeon in inserting the working cannula and in maintaining its three-dimensional position relative to the arthroscope throughout surgery while permitting movement of both portals The desired benefit was to achieve an easy and accurate method to insert and position the working cannula and help minimize intra-articular scuffing and surgical risks The purpose of the present study was to examine the accuracy safety and efficiency of the LOPO guide device
The guide device consists of two arms of equal length each being a double parallelogram A connector holds both arms and permits movement by changing the angle between them One arm is intended to hold the arthroscope while the other is intended for the insertion of the working cannula After the arthroscope is introduced into the joint cavity the guide device is mounted on the base of the arthroscope via one arm The other arm receives the working cannula and owing to the double parallelogram design it directs it to the ideal puncture site and insertion vector and depth into the joint cavity where it has to meet the tip of the arthroscope This results in immediate visualization of the working cannula by the arthroscope and maintains optimal spatial positions between the two portals The connector between the two arms of the device enables changing the angle between them while maintaining the relative position of the tip of the cannula to the tip of the arthroscope The connector can also be locked thus fixating the angle between the two arms
During surgery the surgeon holds the LOPO device with the two cannulas mounted on it with one hand while the other hand is free to perform surgical instrumentation through the working cannula All this is performed while the ideal position of the working cannula relative to the arthroscope is maintained due to the double parallelogram design The guide device can be mounted and dismounted at any time during the operation without the need to remove the cannulas from the joint It is a Patent No US 11517348 B2
Approval for conducting an experiment with human subjects using the LOPO device was granted by the Institutional Review Board IRB approval 4657-17-SMC and the National Ministry of Health MOH_2018-08-27_003619 The clinical trial was registered before enrolment of patients
Adherence to the triangulation principles is essential for achieving a successful placement of the second or working cannula However it takes a considerable amount of time to become proficient in this technique Furthermore maintaining the optimal spatial alignment of the working cannula with the arthroscope throughout the surgery necessitates additional practice experience and synchronized collaboration between the surgeon and assistant
The main author developed a Locator-Positioner LOPO guide device to assist the surgeon in inserting the working cannula and in maintaining its three-dimensional position relative to the arthroscope throughout surgery while permitting movement of both portals The desired benefit was to achieve an easy and accurate method to insert and position the working cannula and help minimize intra-articular scuffing and surgical risks The purpose of the present study was to examine the accuracy safety and efficiency of the LOPO guide device
The guide device consists of two arms of equal length each being a double parallelogram A connector holds both arms and permits movement by changing the angle between them One arm is intended to hold the arthroscope while the other is intended for the insertion of the working cannula After the arthroscope is introduced into the joint cavity the guide device is mounted on the base of the arthroscope via one arm The other arm receives the working cannula and owing to the double parallelogram design it directs it to the ideal puncture site and insertion vector and depth into the joint cavity where it has to meet the tip of the arthroscope This results in immediate visualization of the working cannula by the arthroscope and maintains optimal spatial positions between the two portals The connector between the two arms of the device enables changing the angle between them while maintaining the relative position of the tip of the cannula to the tip of the arthroscope The connector can also be locked thus fixating the angle between the two arms
During surgery the surgeon holds the LOPO device with the two cannulas mounted on it with one hand while the other hand is free to perform surgical instrumentation through the working cannula All this is performed while the ideal position of the working cannula relative to the arthroscope is maintained due to the double parallelogram design The guide device can be mounted and dismounted at any time during the operation without the need to remove the cannulas from the joint It is a Patent No US 11517348 B2
Approval for conducting an experiment with human subjects using the LOPO device was granted by the Institutional Review Board IRB approval 4657-17-SMC and the National Ministry of Health MOH_2018-08-27_003619 The clinical trial was registered before enrolment of patients
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