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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Humeral Upper Extremity Fracture, Humeral Diaphysis Fracture

Intervention / Treatment
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* Procedure: Humeral neailling in humeral fractures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Approach through the rotator cuff or through the rotator cuff split
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rotator cuff approach<br>the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery | Procedure: Humeral neailling in humeral fractures<br>* Humeral neailling in humeral fractures<br>|
| Experimental: rotator cuff split approach<br>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<br>* Humeral neailling in humeral fractures<br>|

What is the study measuring?
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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) | 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 | 
| 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective randomized study, Speed of functional recovery, Humeral fractures, Anterograde nailing, Rotator cuff split