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出境医 / 临床实验 / Tendon Transfer for Irreversible Radial Nerve Palsy, Does it Help?Retrospective Cohort From Level-1 Trauma Center.
Tendon Transfer for Irreversible Radial Nerve Palsy, Does it Help?Retrospective Cohort From Level-1 Trauma Center.
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Radial Palsy | Procedure: Tendon transfer |
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
| Study Type : | Observational |
| Actual Enrollment : | 49 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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. |
| Actual Study Start Date : | January 1, 2004 |
| Actual Primary Completion Date : | December 31, 2014 |
| Actual Study Completion Date : | December 31, 2014 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Procedure: Tendon transfer
flexor carpi radialis transfer in most of patients and boye-transfer in very few
|
Outcome Measures
Primary Outcome Measures :
- Functional outcome - Range of Motion [ Time Frame: 6 months ]Range of Motion at hand and wrist joints, fingers extension, wrist extension
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
participants with presenting due to late consequence of trauma affecting their hand and wrist function due to irreversible damage to radial nerve
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 2, 2019 | ||||
| First Posted Date | May 3, 2019 | ||||
| Last Update Posted Date | May 3, 2019 | ||||
| Actual Study Start Date | January 1, 2004 | ||||
| Actual Primary Completion Date | December 31, 2014 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Functional outcome - Range of Motion [ Time Frame: 6 months ] Range of Motion at hand and wrist joints, fingers extension, wrist extension
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Tendon Transfer for Irreversible Radial Nerve Palsy, Does it Help?Retrospective Cohort From Level-1 Trauma Center. | ||||
| 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. | ||||
| Brief 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. 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | participants with presenting due to late consequence of trauma affecting their hand and wrist function due to irreversible damage to radial nerve | ||||
| Condition | Radial Palsy | ||||
| Intervention | Procedure: Tendon transfer
flexor carpi radialis transfer in most of patients and boye-transfer in very few
|
||||
| Study Groups/Cohorts | 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
Intervention: Procedure: Tendon transfer
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
49 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2014 | ||||
| Actual Primary Completion Date | December 31, 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03936868 | ||||
| Other Study ID Numbers | 2019-0845-3203 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Obada Hasan, FCPS, MRCS, Aga Khan University | ||||
| Study Sponsor | Aga Khan University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Aga Khan University | ||||
| Verification Date | May 2019 | ||||
