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COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Minimally Invasive Chevron/Akin osteotomy
Open Scarf/Akin osteotomy
Sponsored by
Northumbria Healthcare NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age.
  • Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures.
  • Patients with no significant co-morbidities that would increase their risk of procedure.
  • Patients able to understand and complete questionnaires.
  • Patients with the capacity to provide informed consent.
  • Patients who have, in addition to Hallux Valgus Deformity, lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure.
  • Patients without significant other mid foot or hind foot pathology

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients with severity of Hallux valgus deformity necessitating Open procedure
  • Patients with significant co-morbidities that would increase the risk of surgery
  • Patients unable to understand or complete questionnaires.
  • Patients without the capacity to provide informed consent.
  • Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint.

Sites / Locations

  • Northumbria NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimally Invasive Chevron/Akin osteotomy

Open Scarf/Akin osteotomy

Arm Description

Minimally invasive technique to surgically correct Hallux Valgus

Open technique to surgically correct Hallux Valgus

Outcomes

Primary Outcome Measures

Number of patients recruited
The number of patients able to be recruited and retained in this feasibility study. This will determine if a larger study can go forward.

Secondary Outcome Measures

Patient reported outcomes assessed by questionnaire
Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.
MTPJ range of movement in degrees
Measured preoperatively at 6 weeks and 6 months by goniometer
Complications

Full Information

First Posted
September 21, 2016
Last Updated
March 8, 2021
Sponsor
Northumbria Healthcare NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02915822
Brief Title
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
Official Title
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria Healthcare NHS Foundation Trust

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
The aim of this study is to assess the feasibility of conducting a study to compare the patient recorded and clinical outcomes for the surgical management of Hallux Valgus correction. A prospective trial will randomise the patients into two groups - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy.
Detailed Description
This study will assess the feasibility of a prospective trial that would randomise the patients into two groups for surgical correction of Hallux Valgus - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy. Patients will complete a validated questionnaire (Manchester Oxford Foot questionnaire) preoperatively and post operatively at 6 months and 1 year. Range of motion of the Great Toe Metatarsal Phalangeal Joint will also be measured by goniometer. This study will assess the ability to recruit and retain patients and thus determine if a study comparing the surgical techniques would be feasible. In addition, for data collected statistical differences of the change in patient reported outcomes, range of motion between the two groups will be calculated with a significance level of p<0.05. This study will assess if a larger study comparing minimally invasive to open Hallux Valgus correction would be able to be performed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Chevron/Akin osteotomy
Arm Type
Experimental
Arm Description
Minimally invasive technique to surgically correct Hallux Valgus
Arm Title
Open Scarf/Akin osteotomy
Arm Type
Active Comparator
Arm Description
Open technique to surgically correct Hallux Valgus
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Chevron/Akin osteotomy
Intervention Description
Minimally invasive technique for hallux valgus correction
Intervention Type
Procedure
Intervention Name(s)
Open Scarf/Akin osteotomy
Intervention Description
Open technique for Hallux Valgus correction
Primary Outcome Measure Information:
Title
Number of patients recruited
Description
The number of patients able to be recruited and retained in this feasibility study. This will determine if a larger study can go forward.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient reported outcomes assessed by questionnaire
Description
Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.
Time Frame
1 year
Title
MTPJ range of movement in degrees
Description
Measured preoperatively at 6 weeks and 6 months by goniometer
Time Frame
6 months
Title
Complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age. Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures. Patients with no significant co-morbidities that would increase their risk of procedure. Patients able to understand and complete questionnaires. Patients with the capacity to provide informed consent. Patients who have, in addition to Hallux Valgus Deformity, lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure. Patients without significant other mid foot or hind foot pathology Exclusion Criteria: Patients under 18 years of age Patients with severity of Hallux valgus deformity necessitating Open procedure Patients with significant co-morbidities that would increase the risk of surgery Patients unable to understand or complete questionnaires. Patients without the capacity to provide informed consent. Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Bunn
Phone
0044 344 811 8111
Ext
4548
Email
ResearchAndDevelopment@northumbria-healthcare.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajeshkumar Kakwani
Organizational Affiliation
Northumbria Healthcare NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Northumbria NHS Foundation Trust
City
Newcastle upon Tyne
State/Province
Northumbria
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Bunn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

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