The main objective is to investigate if splintless approach improve the surgical accuracy of MMA for OSA. The secondary objectives are to assess the effect of splintless MMA on duration of surgery, blood loss, adverse events, respiration function,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Sleep-related breathing disorder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the accuracies of MMA surgical movements in
anteroposterior translation and counterclockwise rotation of the maxilla and
mandible. This makes a total of four primary study variables.
Secondary outcome
A) Other translation parameters (mediolateral, superoinferior) of the maxilla
and mandible, and rotation parameters (roll, yaw) of the maxilla and mandible;
B) Duration of surgery;
C) Blood loss during surgery;
D) Intra- and post-operative adverse events/complications;
E) Sleep study measures;
F) Daytime sleepiness as assessed with Epworth sleep scale (ESS);
G) Functional status as assessed with Functional Outcomes of Sleep
Questionnaire (FOSQ);
H) Sleep quality as assessed with Pittsburgh Sleep Quality Index (PSQI);
I) Patient*s health status as assessed with EuroQoL 5-dimension 5-level
questionnaire (EQ-5D-5L);
J) Quality of life as assessed with 36-Item Short Form Survey (SF-36);
K) Oral health-related quality-of-life as assessed with Oral Health Impact
Profile (OHIP-14);
L) Mandibular function as assessed with the Mandibular Function Impairment
Questionnaire (MFIQ);
M) Patient*s satisfaction with facial appearance as assessed with FACE-Q;
N) Patient*s satisfaction with surgery outcomes as assessed with customized
patient satisfaction questionnaire;
O) Bed partner*s opinion on patient*s surgery outcomes as assessed with bed
partner questionnaire;
P) Postsurgical relapse measures in translation parameters and rotation
parameters of the maxilla and mandible;
Q) Facial soft tissue changes following MMA at various soft-tissue points using
3D tereophotogrammetry;
R) Upper airway variables on CT;
S) Blood pressure;
T) Incremental cost-effectiveness ratio (ICER) and incremental cost-utility
ratio (ICUR).
Background summary
Maxillomandibular advancement (MMA) surgery is a specific type of orthognathic
surgery, which is now frequently used for the treatment of obstructive sleep
apnea (OSA). The current gold standard for orthognathic surgery is to virtually
plan the procedure in three dimensions (3D) and transfer the surgical planning
to the operating room with 3D-printed intermediate and final surgical splints.
A novel method to transfer surgical planning is the use of patient-specific
osteotomy guides and fixation implants, without the need for surgical splints
(i.e., splintless approach), which has demonstrated higher surgical accuracy
than the conventional approach. However, to date no studies have evaluated
whether the splintless approach provides similar advantages for MMA surgery in
OSA treatment, with extremely large advancement and counterclockwise rotation.
Additionally, the effect of MMA using splintless approach (i.e., splintless
MMA) on functional outcome parameters in OSA patients has never been
investigated.
Study objective
The main objective is to investigate if splintless approach improve the
surgical accuracy of MMA for OSA.
The secondary objectives are to assess the effect of splintless MMA on duration
of surgery, blood loss, adverse events, respiration function, subjective
outcomes, skeletal stability, facial esthetics, upper airway dimension, blood
pressure, and cost-effectiveness.
Study design
Prospective randomized intervention study
Intervention
In the intervention group, splintless MMA will be performed as an experimental
treatment. In the control group, conventional MMA using surgical splints (i.e.,
splint MMA) will be executed.
Study burden and risks
The application of patient-specific guides and implants in orthognathic surgery
is not a novel technique, however, it is not yet applied for this indication
and is considered an experimental treatment for OSA. Risks during the
splintless MMA surgery may include incompetent fit of the guides or implants,
positioning errors, or failure of the guides (i.e., fracturing of the guide).
In our experience and literature, these events have not happened in clinical
practice so far. Therefore, the risks related to participation are negligible.
All study procedures are performed during routine clinical practice, there is
no extra burden of site visits for patients. At baseline and follow-ups,
patients have to receive anthropometric measurements, blood pressure
measurements, and fill out multiple questionnaires online. Besides, patients
have to receive an extra CT scan (24 months after MMA) and an overnight sleep
study (60 months after MMA).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Adults aged 18 years or older;
Moderate to severe OSA as determined by an overnight polysomnography (PSG)
preoperatively;
Continunous positive airway pressure failure or intolerance;
General good health for surgery;
MMA surgery indicated for OSA treatment.
Exclusion criteria
Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le
Fort I osteotomy, temporomandibular joint reconstruction);
Previous history of orthognathic surgery;
Cleft palate and syndromic patients;
Refusal to participate.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85211.018.24 |