Comparing surgical and non-surgical treatment for jaw fractures
Condylar Head Operative or Conservative 1, Randomised Controlled Trial
This study is testing whether surgery or non-surgical treatment works better for people with jaw fractures to see which option helps them feel better and improves their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Locations | 2 sites (Coventry, Warwickshire and 1 other locations) |
| Trial ID | NCT03264196 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of surgical versus conservative management for displaced fractures of the condylar head of the mandible. It aims to provide clarity on which treatment approach yields better patient-reported outcomes related to jaw function and quality of life. Participants will be randomly assigned to receive either open reduction and internal fixation surgery or conservative treatment involving advice and exercises. The study will focus on patient perceptions rather than solely objective measures, addressing the current lack of consensus in the medical literature regarding the best management strategy for these fractures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral condylar head fractures that are displaced by at least 2 mm.
Not a fit: Patients with undisplaced condylar head fractures or those with bilateral fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance for patients and clinicians on the most effective treatment for condylar head fractures, potentially improving recovery outcomes.
How similar studies have performed: While there is conflicting evidence in existing literature, this trial aims to address gaps in knowledge, making it a novel approach to a common clinical dilemma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial. * Male or Female, aged 18 years or above. * Be in good health - suitable for general anaesthesia for surgical treatment * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial. * Unilateral condylar head fracture with or without other mandibular body or angle fractures, or other maxillofacial injuries * Condylar head fracture displaced by at least 2 mm measured on coronal or sagittal CT scan * In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: * Undisplaced condylar head fractures, or displaced less than 2 mm on coronal or sagittal CT * Bilateral condylar head fractures * Pre-existing congenital or acquired pathology of the ipsilateral or contralateral temporomandibular joint - including but not limited to ankylosis, inflammatory arthropathy, idiopathic condylar resorption * Pregnancy (increased risk of joint pain and laxity)
Where this trial is running
Coventry, Warwickshire and 1 other locations
- University Hospital Coventry — Coventry, Warwickshire, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Niall MH Mcleod, FRCS(OMFS) — Oxford University Hospitals
- Study coordinator: Niall MH McLeod, FRCS(OMFS)
- Email: niall.mcleod@nhs.net
- Phone: 01865743102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.