Humeral Diaphysis Fracture Clinical Trial
— HUNAAPOfficial 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
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01116349 -
Conservative Treatment Versus the Surgical Treatment of Diaphyseal Fractures of Humerus
|
N/A |