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)

NCT04917536 | Completed

• 2 other identifiers: RBHP 2021 VILLATTE2021-A00400-41
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Humeral Upper Extremity Fracture; Humeral Diaphysis Fracture

Keywords

Speed of functional recovery; Humeral fractures; Anterograde nailing; Rotator cuff split; Prospective randomized study

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (38)

• Quick Dash

  Day 21

• Quick Dash

  Day 45

• Quick Dash

  Month 3

• Quick Dash

  Month 6

• Quick Dash

  Month 12

Study Arms (2)

rotator cuff approach

ACTIVE COMPARATOR

the nail is inserted through the supra-spinatus tendon, which is closed at the end of the surgery

Procedure: Humeral neailling in humeral fractures

rotator cuff split approach

EXPERIMENTAL

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

Interventions

Humeral neailling in humeral fractures PROCEDURE

Humeral neailling in humeral fractures

rotator cuff approach; rotator cuff split approach

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Guillaume Villatte

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Approach through the rotator cuff or through the rotator cuff split

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 8, 2021
• Study Start: June 21, 2021
• Primary Completion: June 1, 2025
• Study Completion: November 20, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)