Can Hypermobility of First Ray Affect Surgical Treatment... | NCT05051709

Studies
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus

NCT05051709

Sponsor

Hawler Medical University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Hallux Valgus

Interventions

Corrective osteotomy
Fusion of First ray

Countries

Iraq

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2021Estimated

Primary Completion Date

Sep 15, 2022Estimated

Completion Date

Sep 15, 2023Estimated

First Submitted Date

Sep 11, 2021

First Submission Date that Met QC Criteria

Sep 11, 2021

First Posted Date

Sep 21, 2021Actual

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

Sep 11, 2021

Last Update Posted Date

Sep 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherwan Ahmed Ali Hamawandi, Assistant professor of orthopedic surgery, Hawler Medical UniversityPrincipal Investigator

Lead Sponsor

Hawler Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hallux valgus can be associated with hypermobility of 1st ray. Surgical decision for hallux valgus can be affected by hyper mobility of 1st ray so our clinical trial involved patients with bilateral hallux valgus were planned to underwent fusion of 1st ray and soft tissue correction plus bonionectomy for one foot and for other foot surgical treatment involves corrective osteotomy and soft tissue procedure plus bonionectomy without fusion of 1st tarsometatarsal joint.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Foot with no fusion	Active Comparator		Procedure: Corrective osteotomy
Foot with fusion	Active Comparator		Procedure: Fusion of First ray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corrective osteotomy	Procedure	First metatarsal distal corrective osteotomy	Foot with no fusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American foot and ankle score	American foot and ankle score involved 9 section	This score was assessed one year after surgery
Foot and Ankle Disability Index	Foot and Ankle Disability Index involved 26 sections	This score was assessed one year after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hallux Valgus with 1st ray hypermobility

Exclusion Criteria:

Generalized Ligament laxity
Previous foot and ankle surgery
Diabetes Mellitus

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherwan Hamawndi, Ass. prof.	Contact	009644464321		sherwan.hamawandi@hmu.edu.krd

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hawler Medica University	Recruiting	Erbil		44001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Later we will decide

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided