NCT05283785

Brief Summary

This study will evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 2, 2022

Last Update Submit

March 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluate the hand intrinsic muscles functional recovery after distal neurotization of ulnar nerve

    (1) Evaluation of hand intrinsic muscle functional recovery by : A- Muscle power by standard Medical Research Council (MRC) grading B- grip strength by dynamometer C- pinch strength will done based on grading of adductor pollicis muscle. D- Evaluation of clawing will done based on clinical observation E- DASH( Disabilities of the Arm, Shoulder and Hand ) score pre and post

    8 months

Study Arms (2)

( group 1)

End to End sutures

Procedure: End To End or End to side sutures

( group 2 )

End to Side sutures

Procedure: End To End or End to side sutures

Interventions

End to end or End to side sutures of ulnar nerve by nerve to quadratus muscle ( branch of anterior interosseous nerve )

( group 1)( group 2 )

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. test adductor pollicis muscle. 2. test palmar inter-osseii. 3. test dorsal inter-osseii. 4. test lumbricals. * Investigations: * Radiological: * Plain X-ray * EMG and nerve conduction velocity * Laboratory : Full laboratory investigations Steps of action and techniques used: Pre-operative preparation: 1. recording of pre-existing muscle power, 2. Clarifying of realistic goals before the surgery, 3. anti-biotic within 1 hour before surgery\> . Surgical techniques transfer of the motor branch of the anterior interosseous nerve that supply pronator quadrates muscle to the motor division of the ulnar nerve ( the deep branch of the ulnar nerve ) by end to end or end to side suture

You may qualify if:

  • Site of the injury: at or proximal to level of the elbow
  • Nature of the injury; post traumatic injury.
  • Sex; both males and females.
  • Age; any age.
  • Time of presentation of injury: less than 6 months from injury.

You may not qualify if:

  • Any patient with non-post traumatic injury either inflammatory or tumor caused palsy or idiopathic.
  • Any distal injury below origin of FCU branch.
  • Delayed presentation after 6 months of injury.
  • Any patient refusing participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Amr El-Sayed A Ibrahim, Prof Dr

    Orthopedic and Microsurgery department , assiut university hospital

    STUDY DIRECTOR
  • Yasser M Farouk Ragheb, Lecturar

    Orthopedic and Microsurgery department , assiut university hospital

    STUDY DIRECTOR

Central Study Contacts

Mario S Shawkey Basilios, resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at orthopedic department , assuit university hospital

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 17, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

March 31, 2022

Record last verified: 2022-03