ArthroscopyNCT05995795
Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy
An observational study of Arthroscopy, run by Assiut University.
Trial summary
The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy without any further intervention as tendon transfer. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscopy
- What is being tested?
- ARTHROSCOY
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with brachial plexus injury operated or not with internal rotation contracture
Who may be able to join
- children from 1 year to 15years of age.
- all genders
- patients with brachial plexus injury operated or not with internal rotation contracture
- patient with traumatic brachial plexus injury have residual internal rotation contracture
Who cannot join
- History of septic shoulder
- Flail anaethetic limb
- glenohumeral posterior sublaxation or dislocation in CT
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy without any further intervention as tendon transfer.
Read the detailed description
Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a remaining imbalance causing severe functional impairment . In addition to diminished function, prolonged muscle contractures result in bony deformities in both the glenoid and proximal humerus. Internal rotation contractures due to external rotational weakness are the most common deformity in OBPP. Contracture release, tendon transfers, and rotational osteotomies are surgical methods used, depending on the level of deformity and the patient's age. To achieve functional external rotation of the arm, contracted structures should be released first. Currently, there is a lack of consensus on which procedures over the best outcome for mobility and function, and what are the precise indications for each type of surgery. There is also a large variation of practice between centers
- Conditions
- Arthroscopy
- Being tested
- ARTHROSCOY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTHROSCOYDevice
arthroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with failure of initial intervention
change of improvement of passive and active external rotation of operated shoulder using mallet score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamed Mohamed, Assiut University
- Investigators
- Mohamed Koteb, phD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995795
- Sponsor's protocol ID
- Arthroscopy in OBBP
- Status last verified
- Aug 2023
- First submitted
- 10 May 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.
PubMed 20141905
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT05995795
- Acronym / sponsor ID
- Arthroscopy in OBBP
- Conditions
- Arthroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Aug 2023 (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.
The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy without any further intervention as tendon transfer.
Detailed description
Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a remaining imbalance causing severe functional impairment . In addition to diminished function, prolonged muscle contractures result in bony deformities in both the glenoid and proximal humerus. Internal rotation contractures due to external rotational weakness are the most common deformity in OBPP. Contracture release, tendon transfers, and rotational osteotomies are surgical methods used, depending on the level of deformity and the patient's age. To achieve functional external rotation of the arm, contracted structures should be released first. Currently, there is a lack of consensus on which procedures over the best outcome for mobility and function, and what are the precise indications for each type of surgery. There is also a large variation of practice between centers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with brachial plexus injury operated or not with internal rotation contracture
Key inclusion criteria (4 listed)
- children from 1 year to 15years of age.
- all genders
- patients with brachial plexus injury operated or not with internal rotation contracture
- patient with traumatic brachial plexus injury have residual internal rotation contracture
Key exclusion criteria (3 listed)
- History of septic shoulder
- Flail anaethetic limb
- glenohumeral posterior sublaxation or dislocation in CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTHROSCOYarthroscopy | Device | – |
Primary outcome
Number of participants with failure of initial intervention
Time frame: 1 year
change of improvement of passive and active external rotation of operated shoulder using mallet score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 20141905Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohamed Koteb, phD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopy, run by Assiut University.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOHAMED HAMED, MASTER (01146962067, dr.mohamedelhamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with failure of initial intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995795, which also lists 1 linked publication.
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 16 Aug 2023.