Assessment of incidence of facial nerve functional deficit in open reduction and internal fixation of condylar fractures between transparotid and anterior parotid approach

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/12/029488
• Lead Sponsor: All India Institue of Medical Sciences Raipur

Brief Summary

Patient will be recruited only after approval of the study from the institutional ethics committee- AIIMS-Raipur.

Participant will be included into the study only if they fit in the inclusion criteria provided and after availing informed consent in their own language.

The participant will be followed up for a due course of 3 months after recruitment to achieve the primary objective.

Total duration planned to achieve the sample size= 44 is of 2 years but is subjected to change depending upon the reporting of cases

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-12
• Study Start: 2020-02-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• i.Patients above 12 years of age.
• ii.Patients with unilateral condylar neck and sub-condylar fractures of jaw.
• iii.Patients with bilateral condylar fracture but being surgically treated only on one side.

Exclusion Criteria

i.Fractures of the condylar head ii.Bilateral condylar fractures being surgically reduced on both sides iii.History of operations in the retromandibular region iv.Traumatic open lacerations in the condylar region v.Preoperative injury to the facial nerve or parotid gland vi.Parotid gland disease vii.Overt psychological disturbance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective of assessing the facial nerve function will be done both clinically and using a standard procedure. T pre-framed scales like that of House- Brackmann. Procedural assessment is planned to be done by electrophysiological measures like Electromyography (EMG	Data will be collected using EMG at week 1, week 4, week 12 if feasible

Secondary Outcome Measures

Name	Time	Method
i.Extent of exposure will be reported based on the surgical exposure of the fractured site achieved and the anatomic landmarks of the extent of the exposure. Whether it was adequate or did the surgeon face any particular difficulty with the approach. Linear measurements of the extent of exposure shall be measured on the intraoperative photographs.	ii.Operating time- a stopwatch will be used to measure the time from making an incision to full exposure of the fracture site.

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Raipur, CHHATTISGARH, India

All India Institute of Medical Sciences

🇮🇳Raipur, CHHATTISGARH, India

Dr Santhosh Rao

Principal investigator

9981525599

santhosh@aiimsraipur.edu.in