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)

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: Completed
• Conditions: Humeral Diaphysis Fracture; Humeral Upper Extremity Fracture
• Intervention / Treatment: Procedure: Humeral neailling in humeral fractures

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: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Month 12
Simple shoulder test (SST)	a subjective score to evaluate what kind of activity is actually possible for the patient	day 21
Simple shoulder test (SST)	a subjective score to evaluate what kind of activity is actually possible for the patient	day 45
Simple shoulder test (SST)	a subjective score to evaluate what kind of activity is actually possible for the patient	Month 3
Simple shoulder test (SST)	a subjective score to evaluate what kind of activity is actually possible for the patient	Month 6
Simple shoulder test (SST)	a subjective score to evaluate what kind of activity is actually possible for the patient	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)	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)	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)	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)	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)	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	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	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	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	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	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	Month 12
Duration of the sick leave	The patient is asked when he has returned to his professional activity	day 21
Duration of the sick leave	The patient is asked when he has returned to his professional activity	day 45
Duration of the sick leave	The patient is asked when he has returned to his professional activity	Month 3
Duration of the sick leave	The patient is asked when he has returned to his professional activity	Month 6
Duration of the sick leave	The patient is asked when he has returned to his professional activity	Month 12
Duration of the rehabilitation	The patient is asked about the length of the physiotherapy.	day 21
Duration of the rehabilitation	The patient is asked about the length of the physiotherapy.	day 45
Duration of the rehabilitation	The patient is asked about the length of the physiotherapy.	month 3
Duration of the rehabilitation	The patient is asked about the length of the physiotherapy.	month 6
Duration of the rehabilitation	The patient is asked about the length of the physiotherapy.	month 12
Surgery datas	any or no transfusion of blood cells	during the surgery and immediately after (Day 0)
Surgery datas	time to perform the surgery collected from the operating file in minutes	during the surgery (Day 0)
haemoglobin levels	haemoglobin levels in g/dl	during the surgery and immediately after (Day 0)
Radiological evolution	consolidation or not	Day 45
Radiological evolution	consolidation or not	Month 3
Radiological evolution	consolidation or not	Month 6
Radiological evolution	consolidation or not	Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Guillaume VILLATTE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prospective randomized study; Speed of functional recovery; Humeral fractures; Anterograde nailing; Rotator cuff split
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Humeral Fractures
• Other Study ID 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