Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433154
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-22
Brief Title:
Arthroscopy of the Temporomandibular Joint On Jaw Mobility Pain and HRQoL
Sponsor:
Lund University Hospital
Organization:
Lund University Hospital
Study Overview
Official Title:
Arthroscopic Lysis and Lavage in Patients With Internal Derangement of the Temporomandibular Joint A Retrospective Cohort Study on Jaw Mobility Pain and Health-related Quality of Life
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present study is to retrospectively investigate whether arthroscopic treatment in patients with TMD symptoms depending on internal derangement of the temporomandibular joint TMJ gives a satisfying result on the patients quality of life
Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures PROM evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life
Further the study intends to find out if the patient reported outcome measures PROM on health-related quality of life HRQoL outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint
The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening Secondary the effect of mouth opening on HRQoL is being explored
The primary prediction variable is the surgical treatment Outcome variables are treatment evaluation quality of life PROM based on a validated questionnaire Jaw Functional Limitation Scale JFLS age gender time from diagnosis to treatment severity of symptoms pain mouth opening ability and time from treatment to evaluation
Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures PROM evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life
Further the study intends to find out if the patient reported outcome measures PROM on health-related quality of life HRQoL outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint
The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening Secondary the effect of mouth opening on HRQoL is being explored
The primary prediction variable is the surgical treatment Outcome variables are treatment evaluation quality of life PROM based on a validated questionnaire Jaw Functional Limitation Scale JFLS age gender time from diagnosis to treatment severity of symptoms pain mouth opening ability and time from treatment to evaluation
Detailed Description:
Sample Patients that on referral and examination in 2006 to 2019 at the department of Oral and Maxillofacial Surgery Skåne University Hospital SUS was diagnosed with Temporo Mandibular dysfunction TMD will be recruited for participation in the study Patients aged over 20 years with a dysfunction presenting painful clicking or locking of the Temporomandibular Joint TMJ that underwent an arthroscopic treatment the TMJ on one side will be asked for a follow-up The indication for surgical treatment of these patients was anterior disc displacement combined with pain or Closed Lock disc displacement without reduction The clinical classification is based on general medical history history of dysfunction debut duration frequency character diurnal variation symptoms relief symptoms accentuation clinical recordings muscle palpation joint palpation recordings of jaw movements and provocation maneuvers eg Krogh-Poulsen test The referred patients with TMD were before selected to arthroscopic treatment separated into joint associated TMD or muscular associated TMD Patients with only muscular or mainly muscular symptoms were excluded from arthroscopic treatment and were offered alternative treatment An important measurement for this selection is the Krogh-Poulsen test The surgical treatment was carried out by three Oral and Maxillofacial surgeons with equal clinical experience The sample was during the study period equally distributed between the surgeons Patients with generalized joint disease previous surgical treatment in the TMJ less than 12 months of follow up time andor had additional surgical treatment during the study period will be excluded from the study
Surgical Method Surgical approach to the TMJ was established through a transcutaneous preauricular stab entry with a sharp 19 mm trocar KARL STORZ SE Co KG Tuttlingen Germany to the upper joint compartment A second entry was made with a 1 mm syringe for drainage of the saline solution used for lavage of the upper joint compartment through the trocar cannula Arthroscopic inspection and visual recording of the upper joint compartment was performed with an optical instrument placed through the trocar cannula The optical instrument was replaced by a blunt tip which was used for releasement of adherences between the joint surfaces as well as stretching of the synovia lysis The upper joint compartment was flushed with a minimum of 200ml saline solution lavage Finally 1 ml morphine 10 mgml was injected through the drainage syringe for postoperative pain relief Postoperatively the patient was instructed in a jaw mobility training programme NSAIDs Ibuprofen 400mg orally every 6 to 8 hours and jaw rest not to chew for at seven to thirty days The duration of the postoperative regime was decided at weekly follow-ups
Variables The primary prediction variable is the surgical treatment The primary outcome variable is a treatment evaluation quality of life questionnaire score based on a validated questionnaire Jaw Functional Limitation Scale JFLS The questionnaire will be tested for reliability through repeated recording with at least 2 months gap between for 30 of the patients Other predictor variables that could affect the treatment outcome are age gender time from diagnosis to treatment severity of symptoms pain mouth opening ability time from treatment to evaluation postoperative jaw mobility and improvement of jaw mobility After the patients have been consented for the study they will be asked to fill in the Patient Reported Outcome Measures PROM questionnaire on self-perceived jaw function JFLS The questionnaire will be sent out to all included patients during 2022
Retrospectively the following data will be recorded from patient records gender age at surgery jaw movements pain pre surgical diagnosis clinical and surgical diagnosis arthroscopic
Statistical methods The sample size is based on a total number of 500 patients to be recruited for the enquiry study In addition 4000 patients will be included for analysis of journal records alone Analysis will use mean values confidence intervals standard deviations the Cox regression for evaluation of clinical records treatment outcome and logistic regression for the PROM evaluation Differences in mouth opening and pain scores preoperatively and postoperatively will be compared with McNemars test
Wilcoxons paired-sample test will be used for analyzing mouth opening before and after surgery as a numeric variable Mann-Whitney-test will be used to detect differences between questionnaire responses and clinical findings ie pain and mouth opening The limit for significant difference will be set to p005 Two-sided p-values will be used A correlation analysis Spearman for postoperative mouth opening and JFLS-score and progression of mouth opening and JLFS-score will be used
Surgical Method Surgical approach to the TMJ was established through a transcutaneous preauricular stab entry with a sharp 19 mm trocar KARL STORZ SE Co KG Tuttlingen Germany to the upper joint compartment A second entry was made with a 1 mm syringe for drainage of the saline solution used for lavage of the upper joint compartment through the trocar cannula Arthroscopic inspection and visual recording of the upper joint compartment was performed with an optical instrument placed through the trocar cannula The optical instrument was replaced by a blunt tip which was used for releasement of adherences between the joint surfaces as well as stretching of the synovia lysis The upper joint compartment was flushed with a minimum of 200ml saline solution lavage Finally 1 ml morphine 10 mgml was injected through the drainage syringe for postoperative pain relief Postoperatively the patient was instructed in a jaw mobility training programme NSAIDs Ibuprofen 400mg orally every 6 to 8 hours and jaw rest not to chew for at seven to thirty days The duration of the postoperative regime was decided at weekly follow-ups
Variables The primary prediction variable is the surgical treatment The primary outcome variable is a treatment evaluation quality of life questionnaire score based on a validated questionnaire Jaw Functional Limitation Scale JFLS The questionnaire will be tested for reliability through repeated recording with at least 2 months gap between for 30 of the patients Other predictor variables that could affect the treatment outcome are age gender time from diagnosis to treatment severity of symptoms pain mouth opening ability time from treatment to evaluation postoperative jaw mobility and improvement of jaw mobility After the patients have been consented for the study they will be asked to fill in the Patient Reported Outcome Measures PROM questionnaire on self-perceived jaw function JFLS The questionnaire will be sent out to all included patients during 2022
Retrospectively the following data will be recorded from patient records gender age at surgery jaw movements pain pre surgical diagnosis clinical and surgical diagnosis arthroscopic
Statistical methods The sample size is based on a total number of 500 patients to be recruited for the enquiry study In addition 4000 patients will be included for analysis of journal records alone Analysis will use mean values confidence intervals standard deviations the Cox regression for evaluation of clinical records treatment outcome and logistic regression for the PROM evaluation Differences in mouth opening and pain scores preoperatively and postoperatively will be compared with McNemars test
Wilcoxons paired-sample test will be used for analyzing mouth opening before and after surgery as a numeric variable Mann-Whitney-test will be used to detect differences between questionnaire responses and clinical findings ie pain and mouth opening The limit for significant difference will be set to p005 Two-sided p-values will be used A correlation analysis Spearman for postoperative mouth opening and JFLS-score and progression of mouth opening and JLFS-score will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None