Radial PalsyNCT03936868
Tendon Transfer for Irreversible Radial Nerve Palsy, Does it Help?Retrospective Cohort From Level-1 Trauma Center.
An observational study of Radial Palsy, run by Aga Khan University.
Trial summary
Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radial Palsy
- What is being tested?
- Tendon transfer
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Dec 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: participants with presenting due to late consequence of trauma affecting their hand and wrist function due to irreversible damage to radial nerve
Who may be able to join
- All participants including paediatric and adult age group with irreversible radial nerve palsy and patients with radial nerve palsy with time interval of more than 9 months were included.
Who cannot join
- All participants who underwent radial nerve repair or nerve grafting with or without internal splinting, patients with vascular injuries, muscular dystrophies, CVA (Cerebero-Vascular Accident), Dementia and those with limited followup of less than 3 months were excluded.
About this study
Official title: Tendon Transfer Surgery for Irreversible Radial Nerve Palsy, Does it Help When Expert is Available? Retrospective Cohort From Level-1 Trauma Center in a Metropolitan City.
Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy.
Read the detailed description
Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy. So investigators conducted a retrospective study at Aga Khan University Hospital Karachi comprising records of patients operated for irreversible high radial nerve palsy. Investigators concluded that tendon transfer surgery for radial nerve palsy provides excellent results to restore the lost function and therefore must be considered for patients with no signs of recovery after the nerve repair.
- Conditions
- Radial Palsy
- Being tested
- Tendon transfer
- Medical subject headings
- Radial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon transferProcedure or surgery
flexor carpi radialis transfer in most of patients and boye-transfer in very few
| Study group | Role | What they receive |
|---|---|---|
| Tendon transfer for irreversible radial nerve palsy patient | Tendon transfer for irreversible radial nerve palsy patient who had irreversible damage to radial nerve due to trauma with different mechanism especially gun shot injury Receives: Procedure: Tendon transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome - Range of Motion
Range of Motion at hand and wrist joints, fingers extension, wrist extension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jan 2004
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial PalsyStudies of the same condition, open and under way.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obada Hasan, FCPS, MRCS, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936868
- Sponsor's protocol ID
- 2019-0845-3203
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not having permission from institute.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tendon Transfer Surgery for Irreversible Radial Nerve Palsy, Does it Help When Expert is Available? Retrospective Cohort From Level-1 Trauma Center in a Metropolitan City.
- ClinicalTrials.gov ID
- NCT03936868
- Acronym / sponsor ID
- 2019-0845-3203
- Conditions
- Radial Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 3 May 2019 (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.
Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy.
Detailed description
Radial nerve palsy is associated with serious disability jeopardizing the grasp and power grip accountable to the loss of thumb and fingers extension and loss of active wrist extension respectively. There are three aims in the treatment of radial nerve palsy which comprise the restoration of thumb extension and abduction, finger extension and restoration of wrist extension. In this study we measured the functional outcome after tendon transfer for radial nerve palsy aimed to restore the wrist extension, finger extension and thumb extension/abduction. Investigators' objective was to assess the functional outcome after tendon transfer surgery for radial nerve palsy. So investigators conducted a retrospective study at Aga Khan University Hospital Karachi comprising records of patients operated for irreversible high radial nerve palsy. Investigators concluded that tendon transfer surgery for radial nerve palsy provides excellent results to restore the lost function and therefore must be considered for patients with no signs of recovery after the nerve repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tendon transfer for irreversible radial nerve palsy patient | – | Procedure: Tendon transferTendon transfer for irreversible radial nerve palsy patient who had irreversible damage to radial nerve due to trauma with different mechanism especially gun shot injury |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants with presenting due to late consequence of trauma affecting their hand and wrist function due to irreversible damage to radial nerve
Key inclusion criteria (1 listed)
- All participants including paediatric and adult age group with irreversible radial nerve palsy and patients with radial nerve palsy with time interval of more than 9 months were included.
Key exclusion criteria (1 listed)
- All participants who underwent radial nerve repair or nerve grafting with or without internal splinting, patients with vascular injuries, muscular dystrophies, CVA (Cerebero-Vascular Accident), Dementia and those with limited followup of less than 3 months were excluded.
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 |
|---|---|---|
| Tendon transferflexor carpi radialis transfer in most of patients and boye-transfer in very few | Procedure or surgery | Tendon transfer for irreversible radial nerve palsy patient |
Primary outcome
Functional outcome - Range of Motion
Time frame: 6 months
Range of Motion at hand and wrist joints, fingers extension, wrist extension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No. Not having permission from institute.
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Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
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Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Palsy, run by Aga Khan 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome - Range of Motion (time frame: 6 months). 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 3 May 2019.