Clinical trial NCT04917536: 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)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Humeral Upper Extremity Fracture
Humeral Diaphysis Fracture
Keywords: Speed of functional recovery
Humeral fractures
Anterograde nailing
Rotator cuff split
Prospective randomized study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approach through the rotator cuff or through the rotator cuff split
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speed of functional recovery
timeFrame: Day 21
measure: Speed of functional recovery
timeFrame: Day 45
measure: Speed of functional recovery
timeFrame: Month 3
measure: Speed of functional recovery
timeFrame: Month 6
measure: Speed of functional recovery
timeFrame: Month 12
Secondary outcomes:
measure: Quick Dash
timeFrame: Day 21
measure: Quick Dash
timeFrame: Day 45
measure: Quick Dash
timeFrame: Month 3
measure: Quick Dash
timeFrame: Month 6
measure: Quick Dash
timeFrame: Month 12
measure: Simple shoulder test (SST)
timeFrame: day 21
measure: Simple shoulder test (SST)
timeFrame: day 45
measure: Simple shoulder test (SST)
timeFrame: Month 3
measure: Simple shoulder test (SST)
timeFrame: Month 6
measure: Simple shoulder test (SST)
timeFrame: Month 12
measure: Intensity of Pain
timeFrame: Day 21
measure: Intensity of Pain
timeFrame: Day 45
measure: Intensity of Pain
timeFrame: Month 3
measure: Intensity of Pain
timeFrame: Month 6
measure: Intensity of Pain
timeFrame: Month 12
measure: Complications assessment
timeFrame: day 0
measure: Complications assessment
timeFrame: day 21
measure: Complications assessment
timeFrame: day 45
measure: Complications assessment
timeFrame: Month 3
measure: Complications assessment
timeFrame: Month 6
measure: Complications assessment
timeFrame: Month 12
measure: Duration of the sick leave
timeFrame: day 21
measure: Duration of the sick leave
timeFrame: day 45
measure: Duration of the sick leave
timeFrame: Month 3
measure: Duration of the sick leave
timeFrame: Month 6
measure: Duration of the sick leave
timeFrame: Month 12
measure: Duration of the rehabilitation
timeFrame: day 21
measure: Duration of the rehabilitation
timeFrame: day 45
measure: Duration of the rehabilitation
timeFrame: month 3
measure: Duration of the rehabilitation
timeFrame: month 6
measure: Duration of the rehabilitation
timeFrame: month 12
measure: Surgery datas
timeFrame: during the surgery and immediately after (Day 0)
measure: Surgery datas
timeFrame: during the surgery (Day 0)
measure: haemoglobin levels
timeFrame: during the surgery and immediately after (Day 0)
measure: Radiological evolution
timeFrame: Day 45
measure: Radiological evolution
timeFrame: Month 3
measure: Radiological evolution
timeFrame: Month 6
measure: Radiological evolution
timeFrame: Month 12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Guillaume Villatte
role: PRINCIPAL_INVESTIGATOR
References: