NCT04722081

Brief Summary

Tibial eminence fracture, a bony avulsion of the anterior cruciate ligament (ACL) from its insertion on the intercondylar eminence,1 was first described by Poncet in 1875. 2 Also known as tibial spine fractures, these injuries occur most commonly in skeletally immature patients between the ages of 8 and 14 years

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

6.1 years

First QC Date

January 14, 2021

Last Update Submit

January 21, 2021

Conditions

Tibial Fractures

Keywords

Tibial eminence fractureVirtual reality

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale

    assessment severity of pain

    pain assessment at day 0

  • Visual analogue scale

    assessment severity of pain

    pain assessment at day 180

Secondary Outcomes (2)

  • A universal goniometer

    assessment te range of knee extension at date 0

  • A universal goniometer

    assessment te range of knee extension at date 180

Other Outcomes (2)

  • Pediatric Balance Scale

    assessment of balance at date 0

  • Pediatric Balance Scale

    assessment of balance at date 180

Study Arms (2)

Control Group

EXPERIMENTAL

children received selected physical therapy exercises

Other: physical therapy

Study Group

EXPERIMENTAL

children received selected physical therapy exercises plus virtual reality training

Other: physical therapy

Interventions

physical therapyOTHER

physical therapy-specific exercises

Control GroupStudy Group

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age of children from five to nine
  • children have fracture in tibial eminence

You may not qualify if:

  • children have fracture in tibial eminence grade III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

RECRUITING

Related Publications (3)

  • Young W, Ferguson S, Brault S, Craig C. Assessing and training standing balance in older adults: a novel approach using the 'Nintendo Wii' Balance Board. Gait Posture. 2011 Feb;33(2):303-5. doi: 10.1016/j.gaitpost.2010.10.089. Epub 2010 Nov 18.

    PMID: 21087865BACKGROUND

  • Wilfinger C, Castellani C, Raith J, Pilhatsch A, Hollwarth ME, Weinberg AM. Nonoperative treatment of tibial spine fractures in children-38 patients with a minimum follow-up of 1 year. J Orthop Trauma. 2009 Aug;23(7):519-24. doi: 10.1097/BOT.0b013e3181a13fe4.

    PMID: 19633462BACKGROUND

  • Vander Have KL, Ganley TJ, Kocher MS, Price CT, Herrera-Soto JA. Arthrofibrosis after surgical fixation of tibial eminence fractures in children and adolescents. Am J Sports Med. 2010 Feb;38(2):298-301. doi: 10.1177/0363546509348001. Epub 2009 Dec 23.

    PMID: 20032285BACKGROUND

MeSH Terms

Conditions

Tibial FracturesKnee Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesKnee Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Nehad A Abo-zaid, lecturer

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira H Mohammed, Professor

CONTACT

01144495063amira_hussin77@yahoo.com

Nehad A Abo-zaid, lecturer

CONTACT

01223265216dr.nehadahmed@svu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 25, 2021

Study Start

January 1, 2015

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)