Calcaneal Angles And Postoperative Body Balance Following... | NCT07589192

Studies
Calcaneal Angles And Postoperative Body Balance Following Internal Fixation

NCT07589192

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Body Balnace and Calcaneal Fractures

Interventions

Biodex balance system

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2026Estimated

Primary Completion Date

Jan 15, 2028Estimated

Completion Date

Apr 15, 2028Estimated

First Submitted Date

Apr 29, 2026

First Submission Date that Met QC Criteria

May 9, 2026

First Posted Date

May 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational cross sectionl study is to explore the correlation between Böhler angle and dynamic postural stability indices after calcaneal internal fixation.

in calcaneal fracture post internal fixation both gender, (18-40) yr.

Detailed Description

The goal of this observational cross sectionl study is to explore the correlation between Böhler angle and dynamic postural stability indices after calcaneal internal fixation.

To explore the correlation between Böhler angle and fall risk index after calcaneal internal fixation.
To explore the correlation between Gissane angle and dynamic postural stability indices after calcaneal internal fixation.
To explore the correlation between Gissane angle and fall risk index after calcaneal internal fixation.
To explore if Böhler angle can predict dynamic postural stability indices after calcaneal internal fixation.
To explore if Böhler angle can predict fall risk index after calcaneal internal fixation.
To explore if Gissane angle can predict dynamic postural stability indices after calcaneal internal fixation.
To explore if Gissane angle can predict fall risk index after explore in calcaneal fracture post internal fixation both gender, (18-40) yr, The main questions it aims to answer are: • Will there be a significant correlation between Böhler angle and dynamic postural stability indices after calcaneal internal fixation?
Will there be a significant correlation between Böhler angle and fall risk index after calcaneal internal fixation?
Will there be a significant correlation between Gissane angle and dynamic postural stability indices after calcaneal internal fixation?
Will there be a significant correlation between Gissane angle and fall risk index after calcaneal internal fixation?
Will Böhler angle can significantly predict dynamic postural stability indices after calcaneal internal fixation?
Will Böhler angle can significantly predict fall risk index after calcaneal internal fixation?
Will Gissane angle can significantly predict dynamic postural stability indices after calcaneal internal fixation?
Will Gissane angle can significantly predict fall risk index after calcaneal internal fixation?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single group study		The group of study is the group of intervention who has calcaneal fracture and under wented internl fixation	Diagnostic Test: Biodex balance system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biodex balance system	Diagnostic Test	Assessment for body balance via Biodex Balance System	single group study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Anterior/Posterior stability index (APSI)	Assessment of body balance	single time point
Medial/Lateral stability index (MLSI)	Assessment of body balance	single time point
Overall stability index (OSI)	Assessment of body balance	single time point
Fall Risk index (FRI)	Assessment of risk of fall	single time point
Böhler angle	calcaneal alignment angles	single time point
Gissane angle	calcaneal alignment angles	single time point

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants referred from orthopedic surgeon with calcaneal fracture treated with internal fixation.
Adults aged 18-40 .
Unilateral displaced intra-articular calcaneal fracture .
Underwent internal fixation (plate/screws) .
At least 1 years follow up postoperative .
Able to stand independently.
Both males and females.

Exclusion Criteria:

Problems with cognition, vision, or any other medical issue that might compromise their ability to safely engage in the selected balancing measures should be avoided .
Those with foot or ankle sensitivity loss and a systemic inflammatory illness, including diabetes mellitus, rheumatoid arthritis, or ankylosing spondylitis .
Patients with vestibular or neurological disorders .
Accompanying lower limb and spine fractures, which required internal fixation, talus fractures, thoracolumbar burst fractures, femur fractures, and tibia fractures), severe knee arthrosis, postoperative osteomyelitis of the calcaneus, and subtalar arthrodesis performed before this study because of subtalar arthrosis and pain .
Patients who had lower limb dysfunction; and women who are pregnant and are in their lactation period .
Refusal to give informed consent to participate in the study .
Any associated fracture, bilateral fractures, associated peroneal tendon dislocation, postoperative wound breakdown and superficial or deep infection, age younger than .
Calcaneal heel spur
Foot deformity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

volunteers from both genders aged from 18 to 40 y who had calcaneal fracture and anderwent internal fixation will participate in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nassif M Mousa, Master	Contact	+201273152233	0201011980133	nassif.magdy.mousa@gmail.com
Azza M Abdelmohsen, Assistant Professor of Biomech	Contact	0201145046304		dr_azzamohammed@yahoo.com

Overall Officials

Name	Affiliation	Role
Azza M Abdelmohsen, Assistant Professor of Biomech	Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University / Faculty of Physical Therapy		Cairo	Dokki		Egypt