NCT03938935

Brief Summary

Evaluation of early active postoperative mobilisation in flexor tendon injuries without postoperative splinting

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
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

May 3, 2019

Last Update Submit

May 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Early postoperative mobilisation of fingers (active & passive) - Follow up will be done according to DASH (Disability of arm,shoulder and hand) score at 6 weeks

    one and half month

Interventions

PDS is a Polydioxanone synthetic monofilament which is absorbable.

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient ( \> 16 years)
  • Flexor tendon injuries zones (II,III,IV,V)

You may not qualify if:

  • Patients \< 16 years
  • Flexor tendon injuries zone I
  • Fracture of hand,wrist or forearm bones 3- Associated nerve injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Myer C, Fowler JR. Flexor Tendon Repair: Healing, Biomechanics, and Suture Configurations. Orthop Clin North Am. 2016 Jan;47(1):219-26. doi: 10.1016/j.ocl.2015.08.019.

    PMID: 26614935BACKGROUND

Central Study Contacts

Mina Micheal Anwer, MBBCh

CONTACT

Yasser Mohamed Farouk, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident of Trauma and Orthopedic surgery-Assiut university

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

October 1, 2019

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

May 7, 2019

Record last verified: 2019-05