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)

Humeral Diaphysis Fracture Clinical Trial

— HUNAAP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917536
• Other study ID #: RBHP 2021 VILLATTE
• Secondary ID: 2021-A00400-41
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Diaphysis Fracture
• Humeral Fractures

Intervention

Procedure:
• Humeral neailling in humeral fractures
Humeral neailling in humeral fractures

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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