Temporomandibular Joint Disc DisplacementTMJ-LOPONCT06520917
Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy
A study testing Locator-Positioner (LOPO) Guide Device in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disorders, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Locator-Positioner (LOPO) Guide Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Aug 2018to 18 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with closed lock of the temporomandibular joint (Wilkes stage III internal derangement) based on clinical examination and MRI findings.
- Subjects accepting to participate in the study and undergoing the arthroscopic procedure with the aid of the LOPO device.
- Subjects that are adults (> 18 years), not pregnant, and of sound judgement.
Who cannot join
- Diagnosis of other temporomandibular joint disorders.
- Minor patients under 18 years.
- Pregnant patients.
- Subjects lacking sound judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Accuracy and Safety of a Locator-Positioner Guide Device to Assist in Temporomandibular Joint Arthroscopy
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:
Read more
- 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.
Read the 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 11,517,348 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.
- Conditions
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- Being tested
- Locator-Positioner (LOPO) Guide Device
- Keywords
- Arthroscopy, Arthroscopic surgery, Temporomandibular joint closed lock, Temporomandibular joint
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locator-Positioner (LOPO) Guide DeviceDevice
Patients underwent temporomandibular joint arthroscopy with the aid of the LOPO guide device
| Study group | Role | What they receive |
|---|---|---|
| Performing temporomandibular joint arthroscopy with the aid of the Locator-Positioner (LOPO) Device | Experimental | The patients underwent the arthroscopic procedure of the temporomandibular joint with the guidance of the Locator-Positioner Device Receives: Device: Locator-Positioner (LOPO) Guide Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts made to successfully insert the working cannula into the joint space
After puncturing the skin and advancing to the joint, any partial or complete withdrawal of the cannula followed by a change of vector or depth was considered an additional attempt. Confirmation of successful insertion was based on visualizing the working cannula by the arthroscope (i.e. observing the working cannula on the monitor).
Measured: This outcome is reported during the surgical procedure, as the number of attempts is counted by a resident in the operating room
The duration of time between the arthroscope's insertion into the joint cavity and the initial appearance of the working cannula on the monitor.
The time that elapsed from the point when the arthroscope was inserted in the joint space and the point when the working cannula was seen on the monitor.
Measured: This outcome is reported during the surgical procedure, as the time is measured by a resident in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start31 Aug 2018
- Primary completion30 Jun 2019
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Disc DisplacementStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients that were included in the study underwent temporomandibular joint arthroscopy using the Locator-Positioner Device, as opposed to the usual/classic procedure of temporomandibular joint arthroscopy without the aid of the Locator-Positioner Device
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Waseem Abboud, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520917
- Sponsor's protocol ID
- SMC-4657-17
- Other IDs
- 93765
- Acronym
- TMJ-LOPO
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of the 10 subjects participating in the research will be sent via email upon request to other researchers. Data that can be shared (for each participant): * Age * Gender * Duration of closed lock of the temporomandibular joint * Maximal mouth opening before arthroscopy * Maximal mouth opening after arthroscopy * Number of attempts made to correctly position the working cannula relative to the arthroscope * The time duration between the insertion of the arthroscope and visualization of the working cannula by it
Publications
Abboud WA. Novel guide device for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2020 Sep;49(9):1217-1219. doi: 10.1016/j.ijom.2020.02.013. Epub 2020 Mar 11.
PubMed 32171619Monje Gil F, Hernandez Vila C, Moyano Cuevas JL, Lyra M, Pagador JB, Sanchez Margallo FM. Validation of a simulator for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2016 Jul;45(7):836-41. doi: 10.1016/j.ijom.2016.01.010. Epub 2016 Feb 3.
PubMed 26850940Verde L, Munoz-Guerra MF, Rodriguez-Campo FJ, Escorial V. Temporomandibular Joint: Approach to the Intermediate Space by Triangulation With Transillumination Reference. J Oral Maxillofac Surg. 2023 Jun;81(6):684-688. doi: 10.1016/j.joms.2023.02.008. Epub 2023 Mar 6.
PubMed 36893793Peserico-DalFarra P, Gagliardi-Lugo AF. Training simulation for oral and maxillofacial surgeons based on the techniques of arthroscopy in the temporomandibular joint. Br J Oral Maxillofac Surg. 2019 Nov;57(9):929-931. doi: 10.1016/j.bjoms.2019.08.003. Epub 2019 Aug 22.
PubMed 31445774Slavin AB. Comments on "single-cannula technique for operative arthroscopy using holmium:YAG laser". J Oral Maxillofac Surg. 2012 May;70(5):1014; author reply 1014. doi: 10.1016/j.joms.2012.02.011. No abstract available.
PubMed 22538020McCain JP, Hossameldin RH. Advanced arthroscopy of the temporomandibular joint. Atlas Oral Maxillofac Surg Clin North Am. 2011 Sep;19(2):145-67. doi: 10.1016/j.cxom.2011.06.001. No abstract available.
PubMed 21878249Abboud W, Reiter S, Friedman-Rubin P, Shamir D, Peleg O. Guide device to assist in performing arthroscopic surgery of the temporomandibular joint-a preliminary study. J Oral Facial Pain Headache. 2025 Mar;39(1):128-133. doi: 10.22514/jofph.2025.012. Epub 2025 Mar 12.
PubMed 40129430
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accuracy and Safety of a Locator-Positioner Guide Device to Assist in Temporomandibular Joint Arthroscopy
- ClinicalTrials.gov ID
- NCT06520917
- Acronym / sponsor ID
- TMJ-LOPO / SMC-4657-17
- Conditions
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- Keywords
- Arthroscopy, Arthroscopic surgery, Temporomandibular joint closed lock, Temporomandibular joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 25 Jul 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 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.
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 11,517,348 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients that were included in the study underwent temporomandibular joint arthroscopy using the Locator-Positioner Device, as opposed to the usual/classic procedure of temporomandibular joint arthroscopy without the aid of the Locator-Positioner Device
| Arm | Type | Receives |
|---|---|---|
| Performing temporomandibular joint arthroscopy with the aid of the Locator-Positioner (LOPO) Device | Experimental | Device: Locator-Positioner (LOPO) Guide DeviceThe patients underwent the arthroscopic procedure of the temporomandibular joint with the guidance of the Locator-Positioner Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects diagnosed with closed lock of the temporomandibular joint (Wilkes stage III internal derangement) based on clinical examination and MRI findings.
- Subjects accepting to participate in the study and undergoing the arthroscopic procedure with the aid of the LOPO device.
- Subjects that are adults (> 18 years), not pregnant, and of sound judgement.
Key exclusion criteria (4 listed)
- Diagnosis of other temporomandibular joint disorders.
- Minor patients under 18 years.
- Pregnant patients.
- Subjects lacking sound judgement.
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 |
|---|---|---|
| Locator-Positioner (LOPO) Guide DevicePatients underwent temporomandibular joint arthroscopy with the aid of the LOPO guide device | Device | Performing temporomandibular joint arthroscopy with the aid of the Locator-Positioner (LOPO) Device |
Primary outcome
Number of attempts made to successfully insert the working cannula into the joint space
Time frame: This outcome is reported during the surgical procedure, as the number of attempts is counted by a resident in the operating room
After puncturing the skin and advancing to the joint, any partial or complete withdrawal of the cannula followed by a change of vector or depth was considered an additional attempt. Confirmation of successful insertion was based on visualizing the working cannula by the arthroscope (i.e. observing the working cannula on the monitor).
The duration of time between the arthroscope's insertion into the joint cavity and the initial appearance of the working cannula on the monitor.
Time frame: This outcome is reported during the surgical procedure, as the time is measured by a resident in the operating room
The time that elapsed from the point when the arthroscope was inserted in the joint space and the point when the working cannula was seen on the monitor.
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 25 Jul 2024.
- Background: PubMed 32171619Abboud WA. Novel guide device for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2020 Sep;49(9):1217-1219. doi: 10.1016/j.ijom.2020.02.013. Epub 2020 Mar 11.
- Background: PubMed 26850940Monje Gil F, Hernandez Vila C, Moyano Cuevas JL, Lyra M, Pagador JB, Sanchez Margallo FM. Validation of a simulator for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2016 Jul;45(7):836-41. doi: 10.1016/j.ijom.2016.01.010. Epub 2016 Feb 3.
- Background: PubMed 36893793Verde L, Munoz-Guerra MF, Rodriguez-Campo FJ, Escorial V. Temporomandibular Joint: Approach to the Intermediate Space by Triangulation With Transillumination Reference. J Oral Maxillofac Surg. 2023 Jun;81(6):684-688. doi: 10.1016/j.joms.2023.02.008. Epub 2023 Mar 6.
- Background: PubMed 31445774Peserico-DalFarra P, Gagliardi-Lugo AF. Training simulation for oral and maxillofacial surgeons based on the techniques of arthroscopy in the temporomandibular joint. Br J Oral Maxillofac Surg. 2019 Nov;57(9):929-931. doi: 10.1016/j.bjoms.2019.08.003. Epub 2019 Aug 22.
- Background: PubMed 22538020Slavin AB. Comments on "single-cannula technique for operative arthroscopy using holmium:YAG laser". J Oral Maxillofac Surg. 2012 May;70(5):1014; author reply 1014. doi: 10.1016/j.joms.2012.02.011. No abstract available.
- Background: PubMed 21878249McCain JP, Hossameldin RH. Advanced arthroscopy of the temporomandibular joint. Atlas Oral Maxillofac Surg Clin North Am. 2011 Sep;19(2):145-67. doi: 10.1016/j.cxom.2011.06.001. No abstract available.
- Derived from this study: PubMed 40129430Abboud W, Reiter S, Friedman-Rubin P, Shamir D, Peleg O. Guide device to assist in performing arthroscopic surgery of the temporomandibular joint-a preliminary study. J Oral Facial Pain Headache. 2025 Mar;39(1):128-133. doi: 10.22514/jofph.2025.012. Epub 2025 Mar 12.
- Individual participant dataSharing planned: Yes. Data of the 10 subjects participating in the research will be sent via email upon request to other researchers. Data that can be shared (for each participant): * Age * Gender * Duration of closed lock of the temporomandibular joint * Maximal mouth opening before arthroscopy * Maximal mouth opening after arthroscopy * Number of attempts made to correctly position the working cannula relative to the arthroscope * The time duration between the insertion of the arthroscope and visualization of the working cannula by it
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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.
Waseem Abboud, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locator-Positioner (LOPO) Guide Device in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disorders, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 4 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 25 Jul 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 Israel. 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?
Number of attempts made to successfully insert the working cannula into the joint space (time frame: This outcome is reported during the surgical procedure, as the number of attempts is counted by a resident in the operating room). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520917, which also lists 7 linked publications.
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 25 Jul 2024.