NCT04088214

Brief Summary

Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 10, 2019

Last Update Submit

September 11, 2019

Conditions

Hallux ValgusHallux Valgus and Bunion

Keywords

Arthroscopy

Outcome Measures

Primary Outcomes (2)

  • HVA

    • Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph

    12 weeks post-surgery

  • HVA

    • Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph

    52 weeks post-surgery

Study Arms (1)

ArtDSTP

EXPERIMENTAL

Arthroscopic lateral soft tissue release

Procedure: Arthroscopic lateral soft tissue release

Interventions

Arthroscopic lateral soft tissue releasePROCEDURE

The arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy.

ArtDSTP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 and legally fit for consent
  • Symptomatic hallux valgus with HVA \>15 degrees

You may not qualify if:

  • Active physical or mental disorders that could affect rehabilitation including
  • Other conditions affecting ambulation: lower limb injury, neuromuscular problems etc.
  • Mental incapacitation
  • Previous hallux valgus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hallux ValgusBunion

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesFoot Deformities, Acquired

Study Officials

  • Samuel KK Ling, MBChB

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

May 1, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)