Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus

September 11, 2019 updated by: Samuel KK Ling, Chinese University of Hong Kong

Case Series Regarding the Efficacy of the Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

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

Exclusion:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ArtDSTP
Arthroscopic lateral soft tissue release
Procedure: Arthroscopic lateral soft tissue release
The arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HVA
Time Frame: 12 weeks post-surgery
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
12 weeks post-surgery
HVA
Time Frame: 52 weeks post-surgery
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
52 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Samuel KK Ling, MBChB, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (ACTUAL)

September 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTEC-2019-0340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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