Back to resultsArthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Primary Purpose
Hallux Valgus, Hallux Valgus and Bunion
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Arthroscopic lateral soft tissue release
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring Arthroscopy
Eligibility Criteria
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
Sites / Locations
- CUHK
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ArtDSTP
Arm Description
Arthroscopic lateral soft tissue release
Outcomes
Primary Outcome Measures
HVA
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
HVA
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Secondary Outcome Measures
Full Information
NCT ID
NCT04088214
First Posted
September 10, 2019
Last Updated
September 11, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04088214
Brief Title
Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Official Title
Case Series Regarding the Efficacy of the Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Hallux Valgus and Bunion
Keywords
Arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ArtDSTP
Arm Type
Experimental
Arm Description
Arthroscopic lateral soft tissue release
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic lateral soft tissue release
Intervention Description
The arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy.
Primary Outcome Measure Information:
Title
HVA
Description
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Time Frame
12 weeks post-surgery
Title
HVA
Description
• Hallux valgus angle (HVA) measured on a weight-bearing DP radiograph
Time Frame
52 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel KK Ling, MBChB
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUHK
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
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