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Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial

Primary Purpose

Hallux Valgus and Bunion (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Open Scarf Osteotomy
Minimally invasive scarf Osteotomy
Sponsored by
Hospital Mutua de Terrassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus and Bunion (Disorder) focused on measuring scarf, minimally invasive surgery, hallux valgus

Eligibility Criteria

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

Inclusion Criteria:

- Patients undergo hallux valgus surgery

Exclusion Criteria:

  • Intermetatarsal angle >20º
  • Previous hallux valgus surgery
  • Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
  • 1st cuneometatarsal instability
  • Infection
  • Vascular ischemia
  • Neuropathy

Sites / Locations

  • Josep TorrentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open Scarf Osteotomy

Minimally invasive scarf Osteotomy

Arm Description

This group of patients will undergo surgery performing an open scarf osteotomy

This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy

Outcomes

Primary Outcome Measures

Hallux valgus angle postoperative
The angle among the first metatarsal and the first phalanx

Secondary Outcome Measures

Intermetatarsal 1-2 angle
The angle among the 1st and the 2nd metatarsal
First metatarso-phalangeal range of movement
The range of movement of the first metatarso-phalangeal joint
Surgery duration
The records of the surgery duration
Irradiation
The records of the radiation during the surgeries

Full Information

First Posted
June 21, 2018
Last Updated
June 29, 2018
Sponsor
Hospital Mutua de Terrassa
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1. Study Identification

Unique Protocol Identification Number
NCT03575338
Brief Title
Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
Official Title
Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Mutua de Terrassa

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 purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.
Detailed Description
Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint. Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery. There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus and Bunion (Disorder)
Keywords
scarf, minimally invasive surgery, hallux valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not know the technique
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Scarf Osteotomy
Arm Type
Active Comparator
Arm Description
This group of patients will undergo surgery performing an open scarf osteotomy
Arm Title
Minimally invasive scarf Osteotomy
Arm Type
Experimental
Arm Description
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
Intervention Type
Procedure
Intervention Name(s)
Open Scarf Osteotomy
Intervention Description
Open Scarf Osteotomy
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive scarf Osteotomy
Intervention Description
Minimally invasive scarf Osteotomy
Primary Outcome Measure Information:
Title
Hallux valgus angle postoperative
Description
The angle among the first metatarsal and the first phalanx
Time Frame
1 year - 2 years
Secondary Outcome Measure Information:
Title
Intermetatarsal 1-2 angle
Description
The angle among the 1st and the 2nd metatarsal
Time Frame
1 year - 2 years
Title
First metatarso-phalangeal range of movement
Description
The range of movement of the first metatarso-phalangeal joint
Time Frame
1 year - 2 years
Title
Surgery duration
Description
The records of the surgery duration
Time Frame
Measurement during the surgery
Title
Irradiation
Description
The records of the radiation during the surgeries
Time Frame
Measurement during the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients undergo hallux valgus surgery Exclusion Criteria: Intermetatarsal angle >20º Previous hallux valgus surgery Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure 1st cuneometatarsal instability Infection Vascular ischemia Neuropathy
Facility Information:
Facility Name
Josep Torrent
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
07522
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
josep torrent, md
Phone
+34658425678
Email
jtorrent@mutuaterrassa.es
Phone
+34658425678
Email
jtorrent@mutuaterrassa.es

12. IPD Sharing Statement

Learn more about this trial

Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial

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