- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05877014
Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults (UNILOCH)
Shaft fractures account for 20% of humeral fractures and 3% of all adult fractures in France, with an estimated incidence of 13 to 20/100,000 people. Men aged 21 to 30 years and women aged 60 to 80 years are particularly affected. Intramedullary nailing is among the standard treatments for humeral shaft fractures (when surgery is required). Once inserted, the nail is locked in order to limit stress on the fractured bone, as well as possible secondary rotational displacements or malunion. Bipolar interlocking (BI) is typically performed on both sides (proximal and distal) of the fracture site. This procedure is performed under radiological control, exposing the patient and care team to radiation (during the entire procedure). The objective of the treatment is to obtain consolidation of the fracture within 12 months, and to limit the occurrence of irreversible complications such as malunion or nonunion (2-10% at 12 months post-surgery). The "unipolar interlocking" (UI) technique has recently been introduced. In this technique, locking is performed only on the proximal side of the fracture site. By avoiding the distal approach, potential complications such as radial nerve damage, with the risk of irreversible paralysis (3.8-14.2% in studies of the BI technique in this indication) or the risk of infection on the distal side can be avoided. It also reduces operative time, and consequently the radiation received by patients and caregivers. However, the UI may be poorly positioned, resulting in malunion that requires revision surgery.
Despite the absence of recommendations due to the lack of existing data, several teams use the UI in routine care. In this context, a descriptive cohort of 121 patients operated on at the Dijon University Hospital5 showed similar rates of consolidation between the 2 techniques (93.8% for UI versus 95.2% for BI, p=0.64), functional scores, and complications, as well as a significant 29% decrease in operating time in the UI group (mean + SD: 63.1±21.3 min versus 88.0±30.1 min for VB, p<0.01). These encouraging results, although limited by the retrospective and observational nature of the data, justify a prospective randomized trial comparing these two techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Pierre MARTZ
- Phone Number: +33 0380293307
- Email: pierre.martz@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21000
- Recruiting
- CHU Dijon Bourgogne
-
Contact:
- Pierre MARTZ
- Phone Number: +33 0380293307
- Email: pierre.martz@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient with written consent
- Patient ≥18 years of age with a diagnosis of humeral shaft fracture (all types in the AO classification) requiring surgical treatment with intramedullary nailing
Exclusion Criteria:
- Person not affiliated to national health insurance
- Patient unable to attend all study visits
- Patient with a pathologic fracture
- Patient with a post-traumatic brachial plexus injury at the time of inclusion
- Patient under court protection, guardianship or legal guardianship
- Pregnant, parturient or breastfeeding woman
- Patient admitted for revision surgery of a humerus fracture (insufficient healing or complication)
- Patient with an acute or chronic, unstable or poorly controlled disease that may interfere with the evaluation of the study objective, as determined by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Unipolar interlocking group
|
EQ-5D-5L and SF-12
CT scan at M9 and then at M12 if the humerus is not consolidated at M6
|
Active Comparator: Bipolar interlocking group
|
EQ-5D-5L and SF-12
CT scan at M9 and then at M12 if the humerus is not consolidated at M6
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients with radiologically assessed bone healing at 12 months
Time Frame: Through study completion, an average of 12 months
|
Through study completion, an average of 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MARTZ PHRCN 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Humeral Shaft Fracture
-
Kolding SygehusOdense University Hospital; Karolinska University Hospital; Zealand University... and other collaboratorsRecruitingFracture Humerus of ShaftSweden, Finland, Denmark, Norway
-
Federal University of São PauloUnknownHumerus Fracture | Fracture of Shaft of HumerusBrazil
-
NYU Langone HealthNot yet recruitingFemoral Shaft Fracture | Tibial Shaft FractureUnited States
-
University of Kansas Medical CenterNot yet recruitingFemoral Neck Fractures | Distal Radius Fractures | Femoral Shaft Fracture | Intertrochanteric Fractures | Patella Fracture | Lisfranc Injuries | Distal Femur Fracture | Calcaneus Fractures | Clavicle Fractures | Proximal Humerus Fractures | Tibial Shaft Fracture With or Without Associated Fibula Fracture | Ankle... and other conditionsUnited States
-
Washington University School of MedicineWithdrawnClosed Fracture of Shaft of Ulna | Closed Fracture of Shaft of RadiusUnited States
-
NYU Langone HealthCompletedHip Fractures | Femoral Shaft FracturesUnited States
-
University Hospital, Clermont-FerrandRecruitingHumeral Diaphysis Fracture | Humeral Upper Extremity FractureFrance
-
Aalborg University HospitalDanish Council for Independent ResearchActive, not recruitingIntramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures (IMVEX)Tibial Shaft FractureDenmark
-
MGH Institute of Health ProfessionsShenzhen People's HospitalCompleted
-
University of British ColumbiaCompleted
Clinical Trials on questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States