Comparison of the Speed of Functional Recovery (Constant Score) Between Two Different Approaches of Humeral Nailing in Humeral Fractures: Through the Rotator Cuff or Through the Rotator Interval Split (HUNAAP)
NCT ID: NCT04917536
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-06-21
2025-11-20
Brief Summary
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The patients included in this study will be randomized to one of the two groups.
The recovery will be evaluated by the Constant score over time, for a year. The main hypothesis is the rotator interval split approach allows a faster functional recovery after humeral nailing, by avoiding opening the rotator cuff.
Detailed Description
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Studies have proven these problems can be due to the entry portal of the nail. Indeed, it is inserted through the supra-spinatus tendon, which means an opening of the rotator cuff even if it is closed at the end of the procedure.
But the rotator interval split in the shoulder can allow to insert the nail through it without opening the cuff or damaging the cartilage. It is located between the anterior side of the supra-spinatus tendon and the posterior side of the long part of the biceps.
The aim of the study is to compare the speed of functional recovery according to the entry portal, which are through the rotator cuff or through the rotator interval split, in humeral fractures treated by anterograde nailing.
The cutaneo-muscular approach will be the same in both groups, namely a trans-deltoid approach.
People will be included in the study after an enlightened and signed consent, afterward they will be randomized to one of the two groups.
To evaluate the primary outcome, the Constant Score will be used to measure the kinetic of the recovery.
The secondary outcomes are residual pain (measured by the VAS an evaluation of complications and a radiological review (two different reviewers) to follow the healing and search any side effects, the sick leave and rehabilitation durations.
The patients need to be available for a one-year follow-up. Each assessment will be checked at 21 and 45 days, and at 3, 6 and 12 months after the surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rotator cuff approach
the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery
Humeral neailling in humeral fractures
Humeral neailling in humeral fractures
rotator cuff split approach
the nail is inserted through the rotator cuff split, between the supra-spinatus tendon and the long part of the biceps
Humeral neailling in humeral fractures
Humeral neailling in humeral fractures
Interventions
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Humeral neailling in humeral fractures
Humeral neailling in humeral fractures
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 and under 70 years old
* Humeral diaphysis fracture or humeral upper extremity articular fracture (Neer 2,3 or 4), needing to be treated by anterograde nailing.
* No growth plates
* Patients covered by the French social security service
* Patients able to give their enlightened consent and to answer the questions asked for the trial
Exclusion Criteria
* Existing bone disease
* Polytrauma
* Other fractures on the same upper limb
* Pathologic fracture
* Medical history of surgery on the same shoulder
* Contra-indication to the surgery or the anesthesia
* Infection on the operating site
* Axillary nerve palsy
* Deltoid dysfunction
* Major disability
* Refusal of participation
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Guillaume Villatte
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2021-A00400-41
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2021 VILLATTE
Identifier Type: -
Identifier Source: org_study_id