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) (HUNAAP)

December 19, 2025 updated by: University Hospital, Clermont-Ferrand

Comparison Between the Entry Portals Through the Rotator Cuff and Through the Rotator Interval Split for Anterograde Humeral Nailing in Humeral Fractures: a Prospective Randomized Study

The aim of the study is to show if there is any speed difference of functional recovery for people with humeral fracture, treated by an anterograde nail, which will be inserted through the rotator cuff (the common way) or through the rotator interval split.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Humeral fractures are the third most common fractures over 65 years and represent 8% of all fractures. The anterograde nailing is known to be an efficient way to treat humeral upper extremity fractures and humeral diaphysis fractures. The main complications of this nailing are pain, shoulder stiffness, rotator cuff tendinitis and impingement.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be available for a one year follow-up
  • 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:

  • Pregmant, breastfeeding or potentially pregmant woman
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: rotator cuff approach
the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery
Procedure: Humeral neailling in humeral fractures
Humeral neailling in humeral fractures
Experimental: 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
Procedure: Humeral neailling in humeral fractures
Humeral neailling in humeral fractures

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speed of functional recovery
Time Frame: Day 21
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
Day 21
Speed of functional recovery
Time Frame: Day 45
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
Day 45
Speed of functional recovery
Time Frame: Month 3
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
Month 3
Speed of functional recovery
Time Frame: Month 6
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
Month 6
Speed of functional recovery
Time Frame: Month 12
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quick Dash
Time Frame: Day 21
subjective test showing any difficulties in the daily living activities, relationships, and evaluating the pain and tingling; all of these items are based on the week before the assessment. It ranges from 0 to 100 more the value is better brought up is the score.
Day 21
Quick Dash
Time Frame: Day 45
subjective test showing any difficulties in the daily living activities, relationships, and evaluating the pain and tingling; all of these items are based on the week before the assessment. It ranges from 0 to 100 more the value is better brought up is the score.
Day 45
Quick Dash
Time Frame: Month 3
subjective test showing any difficulties in the daily living activities, relationships, and evaluating the pain and tingling; all of these items are based on the week before the assessment. It ranges from 0 to 100 more the value is better brought up is the score.
Month 3
Quick Dash
Time Frame: Month 6
subjective test showing any difficulties in the daily living activities, relationships, and evaluating the pain and tingling; all of these items are based on the week before the assessment. It ranges from 0 to 100 more the value is better brought up is the score.
Month 6
Quick Dash
Time Frame: Month 12
subjective test showing any difficulties in the daily living activities, relationships, and evaluating the pain and tingling; all of these items are based on the week before the assessment. It ranges from 0 to 100 more the value is better brought up is the score.
Month 12
Simple shoulder test (SST)
Time Frame: day 21
a subjective score to evaluate what kind of activity is actually possible for the patient
day 21
Simple shoulder test (SST)
Time Frame: day 45
a subjective score to evaluate what kind of activity is actually possible for the patient
day 45
Simple shoulder test (SST)
Time Frame: Month 3
a subjective score to evaluate what kind of activity is actually possible for the patient
Month 3
Simple shoulder test (SST)
Time Frame: Month 6
a subjective score to evaluate what kind of activity is actually possible for the patient
Month 6
Simple shoulder test (SST)
Time Frame: Month 12
a subjective score to evaluate what kind of activity is actually possible for the patient
Month 12
Intensity of Pain
Time Frame: Day 21
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Day 21
Intensity of Pain
Time Frame: Day 45
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Day 45
Intensity of Pain
Time Frame: Month 3
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Month 3
Intensity of Pain
Time Frame: Month 6
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Month 6
Intensity of Pain
Time Frame: Month 12
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Month 12
Complications assessment
Time Frame: day 0
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
day 0
Complications assessment
Time Frame: day 21
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
day 21
Complications assessment
Time Frame: day 45
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
day 45
Complications assessment
Time Frame: Month 3
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Month 3
Complications assessment
Time Frame: Month 6
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Month 6
Complications assessment
Time Frame: Month 12
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Month 12
Duration of the sick leave
Time Frame: day 21
The patient is asked when he has returned to his professional activity
day 21
Duration of the sick leave
Time Frame: day 45
The patient is asked when he has returned to his professional activity
day 45
Duration of the sick leave
Time Frame: Month 3
The patient is asked when he has returned to his professional activity
Month 3
Duration of the sick leave
Time Frame: Month 6
The patient is asked when he has returned to his professional activity
Month 6
Duration of the sick leave
Time Frame: Month 12
The patient is asked when he has returned to his professional activity
Month 12
Duration of the rehabilitation
Time Frame: day 21
The patient is asked about the length of the physiotherapy.
day 21
Duration of the rehabilitation
Time Frame: day 45
The patient is asked about the length of the physiotherapy.
day 45
Duration of the rehabilitation
Time Frame: month 3
The patient is asked about the length of the physiotherapy.
month 3
Duration of the rehabilitation
Time Frame: month 6
The patient is asked about the length of the physiotherapy.
month 6
Duration of the rehabilitation
Time Frame: month 12
The patient is asked about the length of the physiotherapy.
month 12
Surgery datas
Time Frame: during the surgery and immediately after (Day 0)
any or no transfusion of blood cells
during the surgery and immediately after (Day 0)
Surgery datas
Time Frame: during the surgery (Day 0)
time to perform the surgery collected from the operating file in minutes
during the surgery (Day 0)
haemoglobin levels
Time Frame: during the surgery and immediately after (Day 0)
haemoglobin levels in g/dl
during the surgery and immediately after (Day 0)
Radiological evolution
Time Frame: Day 45
consolidation or not
Day 45
Radiological evolution
Time Frame: Month 3
consolidation or not
Month 3
Radiological evolution
Time Frame: Month 6
consolidation or not
Month 6
Radiological evolution
Time Frame: Month 12
consolidation or not
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume VILLATTE, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2021 VILLATTE
  • 2021-A00400-41 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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