An interventional study of Humeral neailling in humeral fractures in Humeral Upper Extremity Fracture and Humeral Diaphysis Fracture, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
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.
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.
175 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.
This study's enrollment of 80 is above the median of 55 across 99 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery
Procedure: Humeral neailling in humeral fractures
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Month 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Time frame: day 21
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Time frame: day 45
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Time frame: Month 3
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Time frame: Month 6
Simple shoulder test (SST)
a subjective score to evaluate what kind of activity is actually possible for the patient
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Time frame: day 21
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Time frame: day 45
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Time frame: Month 3
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Time frame: Month 6
Duration of the sick leave
The patient is asked when he has returned to his professional activity
Time frame: Month 12
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Time frame: day 21
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Time frame: day 45
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Time frame: month 3
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Time frame: month 6
Duration of the rehabilitation
The patient is asked about the length of the physiotherapy.
Time frame: month 12
Surgery datas
any or no transfusion of blood cells
Time frame: during the surgery and immediately after (Day 0)
Surgery datas
time to perform the surgery collected from the operating file in minutes
Time frame: during the surgery (Day 0)
haemoglobin levels
haemoglobin levels in g/dl
Time frame: during the surgery and immediately after (Day 0)
Radiological evolution
consolidation or not
Time frame: Day 45
Radiological evolution
consolidation or not
Time frame: Month 3
Radiological evolution
consolidation or not
Time frame: Month 6
Radiological evolution
consolidation or not
Time frame: Month 12
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand