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RecruitingNCT05877014UNILOCHUpdated Jul 30, 2026

Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults

A Phase 3 interventional study of questionnaires and scanner in Humeral Shaft Fracture, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
390
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Humeral Shaft Fracture
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
390 participants (estimated)

Study arms

  • Experimental
    Unipolar interlocking group

    Other: questionnaires · Other: scanner

  • Active comparator
    Bipolar interlocking group

    Other: questionnaires · Other: scanner

Interventions

  • Otherquestionnaires

    EQ-5D-5L and SF-12

  • Otherscanner

    CT scan at M9 and then at M12 if the humerus is not consolidated at M6

06

What researchers measure

Primary outcomes

  1. The proportion of patients with radiologically assessed bone healing at 12 months

    Time frame: Through study completion, an average of 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05877014
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
May 26, 2023
Start date
Jul 3, 2023
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Pierre MARTZ
Contact
pierre.martz@chu-dijon.fr
0380293307 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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