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Completed

NCT Number: 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)

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.

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Key information

Conditions

Humeral Upper Extremity Fracture Arm Injuries Fractures, Bone Humeral Diaphysis Fracture Humeral Fractures Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Humeral neailling in humeral fractures

Procedure

Humeral neailling in humeral fractures

Primary outcomes

  1. Speed of functional recovery

    Time frame: Day 21

    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)

  2. Speed of functional recovery

    Time frame: Day 45

    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)

  3. Speed of functional recovery

    Time frame: Month 3

    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)

  4. Speed of functional recovery

    Time frame: Month 6

    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)

  5. Speed of functional recovery

    Time frame: Month 12

    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)

Secondary outcomes

  1. Quick Dash

    Time frame: Day 21

    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.

  2. Quick Dash

    Time frame: Day 45

    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.

  3. Quick Dash

    Time frame: Month 3

    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.

  4. Quick Dash

    Time frame: Month 6

    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.

  5. Quick Dash

    Time frame: Month 12

    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.

  6. Simple shoulder test (SST)

    Time frame: day 21

    a subjective score to evaluate what kind of activity is actually possible for the patient

  7. Simple shoulder test (SST)

    Time frame: day 45

    a subjective score to evaluate what kind of activity is actually possible for the patient

  8. Simple shoulder test (SST)

    Time frame: Month 3

    a subjective score to evaluate what kind of activity is actually possible for the patient

  9. Simple shoulder test (SST)

    Time frame: Month 6

    a subjective score to evaluate what kind of activity is actually possible for the patient

  10. Simple shoulder test (SST)

    Time frame: Month 12

    a subjective score to evaluate what kind of activity is actually possible for the patient

  11. Intensity of Pain

    Time frame: Day 21

    Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)

  12. Intensity of Pain

    Time frame: Day 45

    Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)

  13. Intensity of Pain

    Time frame: Month 3

    Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)

  14. Intensity of Pain

    Time frame: Month 6

    Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)

  15. Intensity of Pain

    Time frame: Month 12

    Visual analog scale (VAS) : the pain is quantified by a number from 0 (no pain) to 10 (the worst pain ever known)

  16. Complications assessment

    Time frame: day 0

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  17. Complications assessment

    Time frame: day 21

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  18. Complications assessment

    Time frame: day 45

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  19. Complications assessment

    Time frame: Month 3

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  20. Complications assessment

    Time frame: Month 6

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  21. Complications assessment

    Time frame: Month 12

    Searching any early or late complications, such as neurological or vascular problems, haematoma, infection, dislocation, with a clinical exam or other possible paraclinical exams

  22. Duration of the sick leave

    Time frame: day 21

    The patient is asked when he has returned to his professional activity

  23. Duration of the sick leave

    Time frame: day 45

    The patient is asked when he has returned to his professional activity

  24. Duration of the sick leave

    Time frame: Month 3

    The patient is asked when he has returned to his professional activity

  25. Duration of the sick leave

    Time frame: Month 6

    The patient is asked when he has returned to his professional activity

  26. Duration of the sick leave

    Time frame: Month 12

    The patient is asked when he has returned to his professional activity

  27. Duration of the rehabilitation

    Time frame: day 21

    The patient is asked about the length of the physiotherapy.

  28. Duration of the rehabilitation

    Time frame: day 45

    The patient is asked about the length of the physiotherapy.

  29. Duration of the rehabilitation

    Time frame: month 3

    The patient is asked about the length of the physiotherapy.

  30. Duration of the rehabilitation

    Time frame: month 6

    The patient is asked about the length of the physiotherapy.

  31. Duration of the rehabilitation

    Time frame: month 12

    The patient is asked about the length of the physiotherapy.

  32. Surgery datas

    Time frame: during the surgery and immediately after (Day 0)

    any or no transfusion of blood cells

  33. Surgery datas

    Time frame: during the surgery (Day 0)

    time to perform the surgery collected from the operating file in minutes

  34. haemoglobin levels

    Time frame: during the surgery and immediately after (Day 0)

    haemoglobin levels in g/dl

  35. Radiological evolution

    Time frame: Day 45

    consolidation or not

  36. Radiological evolution

    Time frame: Month 3

    consolidation or not

  37. Radiological evolution

    Time frame: Month 6

    consolidation or not

  38. Radiological evolution

    Time frame: Month 12

    consolidation or not

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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

Acronym: HUNAAP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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