Humeral Upper Extremity FractureHUNAAPNCT04917536
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)
A study testing Humeral neailling in humeral fractures in people with Humeral Upper Extremity Fracture and Humeral Diaphysis Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Humeral Upper Extremity Fracture, Humeral Diaphysis Fracture
- What is being tested?
- Humeral neailling in humeral fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2021to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Contra-indication to the surgery or the anesthesia
- Infection on the operating site
- Axillary nerve palsy
- Deltoid dysfunction
- Major disability
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Humeral neailling in humeral fractures
- Keywords
- Speed of functional recovery, Humeral fractures, Anterograde nailing, Rotator cuff split, Prospective randomized study
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humeral neailling in humeral fracturesProcedure or surgery
Humeral neailling in humeral fractures
| Study group | Role | What they receive |
|---|---|---|
| rotator cuff approach | Active comparator | the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery Receives: Procedure: Humeral neailling in humeral fractures |
| rotator cuff split approach | Experimental | the nail is inserted through the rotator cuff split, between the supra-spinatus tendon and the long part of the biceps Receives: Procedure: Humeral neailling in humeral fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of functional recovery
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)
Measured: Day 21
Speed of functional recovery
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)
Measured: Day 45
Speed of functional recovery
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)
Measured: Month 3
Speed of functional recovery
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)
Measured: Month 6
Speed of functional recovery
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)
Measured: Month 12
Secondary outcomes (38)
Quick Dash
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.
Measured: Day 21
Quick Dash
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.
Measured: Day 45
Quick Dash
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.
Measured: Month 3
Quick Dash
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.
Measured: Month 6
Quick Dash
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.
Measured: Month 12
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Measured: day 21
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Measured: day 45
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Measured: Month 3
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Measured: Month 6
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Measured: Month 12
Intensity of Pain
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Measured: Day 21
Intensity of Pain
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Measured: Day 45
Intensity of Pain
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Measured: Month 3
Intensity of Pain
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Measured: Month 6
Intensity of Pain
Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)
Measured: Month 12
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: day 0
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: day 21
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: day 45
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: Month 3
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: Month 6
Complications assessment
Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams
Measured: Month 12
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Measured: day 21
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Measured: day 45
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Measured: Month 3
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Measured: Month 6
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Measured: Month 12
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Measured: day 21
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Measured: day 45
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Measured: month 3
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Measured: month 6
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Measured: month 12
Surgery datas
any or no transfusion of blood cells
Measured: during the surgery and immediately after (Day 0)
Surgery datas
time to perform the surgery collected from the operating file in minutes
Measured: during the surgery (Day 0)
haemoglobin levels
haemoglobin levels in g/dl
Measured: during the surgery and immediately after (Day 0)
Radiological evolution
consolidation or not
Measured: Day 45
Radiological evolution
consolidation or not
Measured: Month 3
Radiological evolution
consolidation or not
Measured: Month 6
Radiological evolution
consolidation or not
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start21 Jun 2021
- Primary completion1 Jun 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Upper Extremity FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approach through the rotator cuff or through the rotator cuff split
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Villatte, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917536
- Sponsor's protocol ID
- RBHP 2021 VILLATTE
- Other IDs
- 2021-A00400-41
- Acronym
- HUNAAP
- Status last verified
- Dec 2025
- First submitted
- 20 May 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04917536
- Acronym / sponsor ID
- HUNAAP / RBHP 2021 VILLATTE
- Keywords
- Speed of functional recovery, Humeral fractures, Anterograde nailing, Rotator cuff split, Prospective randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approach through the rotator cuff or through the rotator cuff split
| Arm | Type | Receives |
|---|---|---|
| rotator cuff approach | Active comparator | Procedure: Humeral neailling in humeral fracturesthe nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery |
| rotator cuff split approach | Experimental | Procedure: Humeral neailling in humeral fracturesthe nail is inserted through the rotator cuff split, between the supra-spinatus tendon and the long part of the biceps |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Pregmant, breastfeeding or potentially pregmant woman
- Existing bone disease
- Polytrauma
- Other fractures on the same upper limb
- Pathologic fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humeral neailling in humeral fracturesHumeral neailling in humeral fractures | Procedure or surgery | rotator cuff approach, rotator cuff split approach |
Primary outcome
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)
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)
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)
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)
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)
38 secondary outcomes
Quick Dash
Time frame: Day 21
Quick Dash
Time frame: Day 45
Quick Dash
Time frame: Month 3
Quick Dash
Time frame: Month 6
Quick Dash
Time frame: Month 12
Simple shoulder test (SST)
Time frame: day 21
Simple shoulder test (SST)
Time frame: day 45
Simple shoulder test (SST)
Time frame: Month 3
Simple shoulder test (SST)
Time frame: Month 6
Simple shoulder test (SST)
Time frame: Month 12
Intensity of Pain
Time frame: Day 21
Intensity of Pain
Time frame: Day 45
Intensity of Pain
Time frame: Month 3
Intensity of Pain
Time frame: Month 6
Intensity of Pain
Time frame: Month 12
Complications assessment
Time frame: day 0
Complications assessment
Time frame: day 21
Complications assessment
Time frame: day 45
Complications assessment
Time frame: Month 3
Complications assessment
Time frame: Month 6
Complications assessment
Time frame: Month 12
Duration of the sick leave
Time frame: day 21
Duration of the sick leave
Time frame: day 45
Duration of the sick leave
Time frame: Month 3
Duration of the sick leave
Time frame: Month 6
Duration of the sick leave
Time frame: Month 12
Duration of the rehabilitation
Time frame: day 21
Duration of the rehabilitation
Time frame: day 45
Duration of the rehabilitation
Time frame: month 3
Duration of the rehabilitation
Time frame: month 6
Duration of the rehabilitation
Time frame: month 12
Surgery datas
Time frame: during the surgery and immediately after (Day 0)
Surgery datas
Time frame: during the surgery (Day 0)
haemoglobin levels
Time frame: during the surgery and immediately after (Day 0)
Radiological evolution
Time frame: Day 45
Radiological evolution
Time frame: Month 3
Radiological evolution
Time frame: Month 6
Radiological evolution
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Villatte principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humeral neailling in humeral fractures in people with Humeral Upper Extremity Fracture and Humeral Diaphysis Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of functional recovery (time frame: Day 21). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.