Osbtetric Brachial Plexus PalsyCinéLDSSNCT06845228
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
An observational study of Osbtetric Brachial Plexus Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Neonatal brachial plexus palsy is a pathology that remains common and one of its sequelae is lack of external rotation of the shoulder. One of the treatments to increase this range of motion is the transfer of the latissimus dorsi tendon to the infraspinatus muscle. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Osbtetric Brachial Plexus Palsy
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: University hospital patients aged 6 to 18 with obstetrical brachial plexus injuries
Who may be able to join
- Patients aged 6 and 18 years old
- Patients with neonatal brachial plexus
- Patients who had a latissimus dorsi transfer at least two years ago
- Patients with post-operative MRI
- Patients or legal representatives for minors having been informed of the study and having given their informed consent by collection of non-opposition
Who cannot join
- Legal representatives of minor children or patients who do not understand verbal or written explanations in French
- Patients with bilateral brachial plexus injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Franck Fitoussi, PUPH MD, PhD contact
France1 site
Name Service de Chirurgie orthopédique de l'hopital Trousseau
Paris, 75012
Franck Fitoussi, PUPH MD-PhD, 00607287973, franck.fitoussi@aphp.fr
Alexandra Stein, MD, 0033698764317, stein.alexandra@hotmail.com
About this study
Official title: Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation with or Without Release of the Subscapularis, in Patients with Neonatal Brachial Plexus Palsy
Neonatal brachial plexus palsy is a pathology that remains common and one of its sequelae is lack of external rotation of the shoulder. One of the treatments to increase this range of motion is the transfer of the latissimus dorsi tendon to the infraspinatus muscle. The aim of this study is to analyze the long-term three-dimensional kinematic effects of latissimus dorsi transfer with or without subscapularis release on upper limb joints during the five Mallet tasks and their correlation with clinical and MRI parameters.
Predictive factors such as age at the time of the operation, the extent of the damage and the presence of severe preoperative dysplasia, the presence of neosurgery and the age at which this neosurgery was performed will be evaluated.
Read more
The main objective is to evaluate the benefit of releasing the subscapularis during latissimus dorsi transfer surgery in patients with neonatal brachial plexus. This evaluation is done through an analysis of the movement of the upper limb in three dimensions. Kinematic data will be compared between patients with subscapularis release, patients without subscapularis release, and an existing database of unaffected arms.
The secondary objective is to study the correlation between kinematic data and factors that may influence results such as age at the time of surgery, extent of plexus damage, presence of severe preoperative dysplasia , the presence of neosurgery and the age at which this neosurgery was performed. The collection will be done during a single movement analysis session, in a dedicated room at Trousseau hospital, for a duration of approximately 1 hour and 30 minutes.
Part of the equipment designed and manufactured by the Ecole Nationale Supérieure d'Arts et Métiers (ENSAM) for these analyzes will be permanently installed in the analysis room. Other equipment will be installed just before the measurement session and put away at the end. The installation of analysis and measurement equipment as well as the acquisition of data during movements are carried out by ENSAM teacher-researchers or students.
The patient is welcomed into the room by a clinician involved in the study and who will participate in the entire session. In particular, he will carry out a rating of the Mallet score at the start of the session, the placement of sensors for movement analysis, palpation of anatomical points and will give the patient instructions for carrying out the movements.
Read the detailed description
Patients undergoing latissimus dorsi transfer surgery due to a brachial plexus will be summoned to the ENSAM laboratory. Evaluation of upper limb mobility in 3 dimensions using electromagnetic sensors stuck to the skin from the Fastrak group (Polhemus, Colchester, US). Four segments are included in this analysis (trunk, scapula, humerus, forearm) and two joints are considered: scapulathoracic (ST) and glenohumeral (GH). The hardware used from the Fastrack group includes four receivers (defining technical frameworks) and a stylus (used for scanning purposes).
The transmitter is placed just behind the shoulder blade with the subject in a standing position. Two receivers are fixed on rigid supports which are then connected to the forearm using straps. Two other receptors are fixed directly to the skin using double-sided adhesive tape: a first at the level of the sternum and a second on the flat part of the acromial process of the scapula. The fixing is reinforced with adhesive tape above the sensors. The anatomical frameworks are defined for the trunk, humerus and forearm.
The relative positions of the anatomical and technical frames are defined during a static acquisition phase where the anatomical points defining the anatomical frames are digitized using the stylus, the receptors being simultaneously connected to the segments.
Angular kinematic calculations are then carried out using the anatomical frames and sequences described previously. Finally, eight angular movements are studied: Protraction/retraction, Medial/lateral rotation, and Anterior/posterior rotation for the scapulothoracic joint, angular movements of the elevation plane (GHPE) and elevation (GHEle) and internal/external rotation (GHRot) for the glenohumeral joint.
The subject stands with feet a comfortable width apart and the posterior surface of the heel in contact with an L-shaped mark attached to the floor. In the initial position, the upper limbs are placed in the anatomical reference position (arm alongside the body) for all the tasks described below except for the first where the elbow is flexed to 90° with the forearm in a plane sagittal. To mobilize the upper limb in different directions in space, patients are invited to perform the five tasks of the Mallet score:
- First task: external rotation, elbow to the body and flexed to 90°
- Second task: hand to mouth.
- Third task: hand on the back.
- Fourth task: hand to the neck.
- Fifth task: raise the upper limb in the scapular plane. The scapular plane was defined at 40° from the frontal plane. To normalize the movement, a laser is attached to the external part of the arm and the subject is asked to follow with the laser spot a vertical line which crosses the scapular plane and a plane perpendicular to the scapular plane.
The whole procedure will be successively carried out for the pathological and healthy sides of the patient. For a given side, each task will be repeated three times consecutively and the average value obtained from these three trials will be studied.
For these four previous tasks, in the initial position, the upper limbs were placed in the anatomical reference position.
This evaluation is standardized: The orthopedic surgeon is responsible for the placement of the sensors. The entire procedure is performed successively for the involved side and the intact side. Each task was repeated three times consecutively and the average value obtained from these three trials is studied.
Description of kinematic calculations:
Four segments are included in this kinematic analysis (trunk, scapula, humerus, forearm). Three joints are considered: scapula-thoracic (ST), Gleno-humeral (GH), elbow. In addition to these joints, the movements of the humerus in relation to the trunk (HT) and of the trunk in relation to a fixed reference are also studied. Kinematic measurements will be carried out using the Fastrak electromagnetic tracking device (Polhemus, Colchester, US).It includes four receivers (defining four technical landmarks) and a stylus (used for palpation purposes). The transmitter is placed just behind the shoulder blade, with the subject in a standing position. Two receivers are fixed on rigid supports which are connected to the forearm using straps and to the arm using an cuff. Two other receptors will be directly attached to the skin using hypoallergenic double-sided adhesive tape: to the sternum and to the scapula on the flat part of the acromial process. The fixation is reinforced by hypoallergenic adhesive tape above the sensors. Anatomical landmarks are defined for the trunk, scapula, humerus, and forearm as previously described in Maurel et al., 2013 and Herisson et al. 2017.
The relative positions of the anatomical and technical landmarks are defined during a static acquisition phase where the anatomical points defining the anatomical landmarks are digitized using the stylus, the receptors being simultaneously connected to the segments. The angular kinematic calculations are then carried out using the anatomical landmarks and the sequences described previously (Maurel et al., 2013, Herisson et al. 2017, Maurel et al. 2021) and make it possible to obtain the following angular positions:
- For the scapulothoracic joint: protraction/retraction (STPro), medial/lateral rotation (STMed) and anterior/posterior inclination (STTilt)
- For the glenohumeral joint: elevation plane (GHPE), elevation (GHEle) and internal/external rotation (GHRot)
- For the elbow: flexion/extension and pronation/supination.
- For the movement of the humerus in relation to the trunk: flexion-extension (HTFE), abduction/adduction (HTAbAd) and internal/external rotation (HTRot).
- For the trunk in relation to the fixed reference: flexion-extension (TFE), Inclination (TInc) and axial rotation (TRot).
Software already developed by ENSAM will be used for the kinematic calculations described above, making it possible to obtain the initial and final positions and the amplitudes of each of the angles studied.
The secondary endpoint will focus on the search for correlations between the kinematics of the upper limb previously described and factors that may influence the results such as age at the time of the intervention, the presence of neosurgery and the age at which was performed this neosurgery, the extent of the plexus damage and the presence of severe preoperative dysplasia..
MRIs of the affected shoulder are carried out for the usual follow-up of patients with neonatal brachial plexus damage. The last MRIs carried out after the operation will be analyzed in order to determine morphological parameters such as the glenoid version, the type of glenoid deformity , the percentage of anterior coverage of the humeral head, the shape of the head of the humerus;
- Conditions
- Osbtetric Brachial Plexus Palsy
- Keywords
- Osbtetric Brachial Plexus Palsy, cinematic, latissimus dorsi, infraspinatus
What is being measured
The primary outcome is the main question the study is designed to answer.
Mallet Score
The five tasks of the Mallet score:
- First task: external rotation, elbow to the body and flexed to 90°
- Second task: hand to mouth.
- Third task: hand on the back.
- Fourth task: hand to the neck.
- Fifth task: raise the upper limb in the scapular plane. The scapular plane was defined at 40° from the frontal plane. To normalize the movement, a laser is attached to the external part of the arm and the subject is asked to follow with the laser spot a vertical line which crosses the scapular plane and a plane perpendicular to the scapular plane.
The whole procedure will be successively carried out for the pathological and healthy sides of the patient. For a given side, each task will be repeated three times consecutively and the average value obtained from these three trials will be studied
Measured: Through study completion (2 years and 6 month)
Secondary outcomes (1)
Confounding factors
Study the correlation between kinematic data and factors that may influence results such as age at the time of surgery, extent of plexus damage, presence of severe preoperative dysplasia, presence of neosurgery and the age at which this neosurgery was performed
Measured: Through study completion (2 years and 6 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osbtetric Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Fitoussi, PUPH MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845228
- Sponsor's protocol ID
- APHP231773
- Acronym
- CinéLDSS
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation with or Without Release of the Subscapularis, in Patients with Neonatal Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT06845228
- Acronym / sponsor ID
- CinéLDSS / APHP231773
- Conditions
- Osbtetric Brachial Plexus Palsy
- Keywords
- Osbtetric Brachial Plexus Palsy, cinematic, latissimus dorsi, infraspinatus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal brachial plexus palsy is a pathology that remains common and one of its sequelae is lack of external rotation of the shoulder. One of the treatments to increase this range of motion is the transfer of the latissimus dorsi tendon to the infraspinatus muscle. The aim of this study is to analyze the long-term three-dimensional kinematic effects of latissimus dorsi transfer with or without subscapularis release on upper limb joints during the five Mallet tasks and their correlation with clinical and MRI parameters.
Predictive factors such as age at the time of the operation, the extent of the damage and the presence of severe preoperative dysplasia, the presence of neosurgery and the age at which this neosurgery was performed will be evaluated.
The main objective is to evaluate the benefit of releasing the subscapularis during latissimus dorsi transfer surgery in patients with neonatal brachial plexus. This evaluation is done through an analysis of the movement of the upper limb in three dimensions. Kinematic data will be compared between patients with subscapularis release, patients without subscapularis release, and an existing database of unaffected arms.
The secondary objective is to study the correlation between kinematic data and factors that may influence results such as age at the time of surgery, extent of plexus damage, presence of severe preoperative dysplasia , the presence of neosurgery and the age at which this neosurgery was performed. The collection will be done during a single movement analysis session, in a dedicated room at Trousseau hospital, for a duration of approximately 1 hour and 30 minutes.
Part of the equipment designed and manufactured by the Ecole Nationale Supérieure d'Arts et Métiers (ENSAM) for these analyzes will be permanently installed in the analysis room. Other equipment will be installed just before the measurement session and put away at the end. The installation of analysis and measurement equipment as well as the acquisition of data during movements are carried out by ENSAM teacher-researchers or students.
The patient is welcomed into the room by a clinician involved in the study and who will participate in the entire session. In particular, he will carry out a rating of the Mallet score at the start of the session, the placement of sensors for movement analysis, palpation of anatomical points and will give the patient instructions for carrying out the movements.
Detailed description
Patients undergoing latissimus dorsi transfer surgery due to a brachial plexus will be summoned to the ENSAM laboratory. Evaluation of upper limb mobility in 3 dimensions using electromagnetic sensors stuck to the skin from the Fastrak group (Polhemus, Colchester, US). Four segments are included in this analysis (trunk, scapula, humerus, forearm) and two joints are considered: scapulathoracic (ST) and glenohumeral (GH). The hardware used from the Fastrack group includes four receivers (defining technical frameworks) and a stylus (used for scanning purposes).
The transmitter is placed just behind the shoulder blade with the subject in a standing position. Two receivers are fixed on rigid supports which are then connected to the forearm using straps. Two other receptors are fixed directly to the skin using double-sided adhesive tape: a first at the level of the sternum and a second on the flat part of the acromial process of the scapula. The fixing is reinforced with adhesive tape above the sensors. The anatomical frameworks are defined for the trunk, humerus and forearm.
The relative positions of the anatomical and technical frames are defined during a static acquisition phase where the anatomical points defining the anatomical frames are digitized using the stylus, the receptors being simultaneously connected to the segments.
Angular kinematic calculations are then carried out using the anatomical frames and sequences described previously. Finally, eight angular movements are studied: Protraction/retraction, Medial/lateral rotation, and Anterior/posterior rotation for the scapulothoracic joint, angular movements of the elevation plane (GHPE) and elevation (GHEle) and internal/external rotation (GHRot) for the glenohumeral joint.
The subject stands with feet a comfortable width apart and the posterior surface of the heel in contact with an L-shaped mark attached to the floor. In the initial position, the upper limbs are placed in the anatomical reference position (arm alongside the body) for all the tasks described below except for the first where the elbow is flexed to 90° with the forearm in a plane sagittal. To mobilize the upper limb in different directions in space, patients are invited to perform the five tasks of the Mallet score:
- First task: external rotation, elbow to the body and flexed to 90°
- Second task: hand to mouth.
- Third task: hand on the back.
- Fourth task: hand to the neck.
- Fifth task: raise the upper limb in the scapular plane. The scapular plane was defined at 40° from the frontal plane. To normalize the movement, a laser is attached to the external part of the arm and the subject is asked to follow with the laser spot a vertical line which crosses the scapular plane and a plane perpendicular to the scapular plane.
The whole procedure will be successively carried out for the pathological and healthy sides of the patient. For a given side, each task will be repeated three times consecutively and the average value obtained from these three trials will be studied.
For these four previous tasks, in the initial position, the upper limbs were placed in the anatomical reference position.
This evaluation is standardized: The orthopedic surgeon is responsible for the placement of the sensors. The entire procedure is performed successively for the involved side and the intact side. Each task was repeated three times consecutively and the average value obtained from these three trials is studied.
Description of kinematic calculations:
Four segments are included in this kinematic analysis (trunk, scapula, humerus, forearm). Three joints are considered: scapula-thoracic (ST), Gleno-humeral (GH), elbow. In addition to these joints, the movements of the humerus in relation to the trunk (HT) and of the trunk in relation to a fixed reference are also studied. Kinematic measurements will be carried out using the Fastrak electromagnetic tracking device (Polhemus, Colchester, US).It includes four receivers (defining four technical landmarks) and a stylus (used for palpation purposes). The transmitter is placed just behind the shoulder blade, with the subject in a standing position. Two receivers are fixed on rigid supports which are connected to the forearm using straps and to the arm using an cuff. Two other receptors will be directly attached to the skin using hypoallergenic double-sided adhesive tape: to the sternum and to the scapula on the flat part of the acromial process. The fixation is reinforced by hypoallergenic adhesive tape above the sensors. Anatomical landmarks are defined for the trunk, scapula, humerus, and forearm as previously described in Maurel et al., 2013 and Herisson et al. 2017.
The relative positions of the anatomical and technical landmarks are defined during a static acquisition phase where the anatomical points defining the anatomical landmarks are digitized using the stylus, the receptors being simultaneously connected to the segments. The angular kinematic calculations are then carried out using the anatomical landmarks and the sequences described previously (Maurel et al., 2013, Herisson et al. 2017, Maurel et al. 2021) and make it possible to obtain the following angular positions:
- For the scapulothoracic joint: protraction/retraction (STPro), medial/lateral rotation (STMed) and anterior/posterior inclination (STTilt)
- For the glenohumeral joint: elevation plane (GHPE), elevation (GHEle) and internal/external rotation (GHRot)
- For the elbow: flexion/extension and pronation/supination.
- For the movement of the humerus in relation to the trunk: flexion-extension (HTFE), abduction/adduction (HTAbAd) and internal/external rotation (HTRot).
- For the trunk in relation to the fixed reference: flexion-extension (TFE), Inclination (TInc) and axial rotation (TRot).
Software already developed by ENSAM will be used for the kinematic calculations described above, making it possible to obtain the initial and final positions and the amplitudes of each of the angles studied.
The secondary endpoint will focus on the search for correlations between the kinematics of the upper limb previously described and factors that may influence the results such as age at the time of the intervention, the presence of neosurgery and the age at which was performed this neosurgery, the extent of the plexus damage and the presence of severe preoperative dysplasia..
MRIs of the affected shoulder are carried out for the usual follow-up of patients with neonatal brachial plexus damage. The last MRIs carried out after the operation will be analyzed in order to determine morphological parameters such as the glenoid version, the type of glenoid deformity , the percentage of anterior coverage of the humeral head, the shape of the head of the humerus;
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- University hospital patients aged 6 to 18 with obstetrical brachial plexus injuries
Key inclusion criteria (5 listed)
- Patients aged 6 and 18 years old
- Patients with neonatal brachial plexus
- Patients who had a latissimus dorsi transfer at least two years ago
- Patients with post-operative MRI
- Patients or legal representatives for minors having been informed of the study and having given their informed consent by collection of non-opposition
Key exclusion criteria (2 listed)
- Legal representatives of minor children or patients who do not understand verbal or written explanations in French
- Patients with bilateral brachial plexus injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mallet Score
Time frame: Through study completion (2 years and 6 month)
The five tasks of the Mallet score: * First task: external rotation, elbow to the body and flexed to 90° * Second task: hand to mouth. * Third task: hand on the back. * Fourth task: hand to the neck. * Fifth task: raise the upper limb in the scapular plane. The scapular plane was defined at 40° from the frontal plane. To normalize the movement, a laser is attached to the external part of the arm and the subject is asked to follow with the laser spot a vertical line which crosses the scapular plane and a plane perpendicular to the scapular plane. The whole procedure will be successively carried out for the pathological and healthy sides of the patient. For a given side, each task will be repeated three times consecutively and the average value obtained from these three trials will be studied
1 secondary outcome
Confounding factors
Time frame: Through study completion (2 years and 6 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Franck Fitoussi, PUPH MD, PhD contact
Franck Fitoussi, PUPH MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osbtetric Brachial Plexus Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franck Fitoussi, PUPH MD, PhD (franck.fitoussi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mallet Score (time frame: Through study completion (2 years and 6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.