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

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ClinicalTrials.gov Identifier: NCT03575338
Recruitment Status : Unknown
Verified June 2018 by josep torrent, Hospital Mutua de Terrassa.
Recruitment status was:  Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
josep torrent, Hospital Mutua de Terrassa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hallux Valgus and Bunion (Disorder) Procedure: Open Scarf Osteotomy Procedure: Minimally invasive scarf Osteotomy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will not know the technique
Primary Purpose: Treatment
Official Title: Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Open Scarf Osteotomy
This group of patients will undergo surgery performing an open scarf osteotomy
 Procedure: Open Scarf Osteotomy
Open Scarf Osteotomy
Experimental: Minimally invasive scarf Osteotomy
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
 Procedure: Minimally invasive scarf Osteotomy
Minimally invasive scarf Osteotomy


Outcome Measures
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Primary Outcome Measures :
  1. Hallux valgus angle postoperative [ Time Frame: 1 year - 2 years ]
    The angle among the first metatarsal and the first phalanx


Secondary Outcome Measures :
  1. Intermetatarsal 1-2 angle [ Time Frame: 1 year - 2 years ]
    The angle among the 1st and the 2nd metatarsal

  2. First metatarso-phalangeal range of movement [ Time Frame: 1 year - 2 years ]
    The range of movement of the first metatarso-phalangeal joint

  3. Surgery duration [ Time Frame: Measurement during the surgery ]
    The records of the surgery duration

  4. Irradiation [ Time Frame: Measurement during the surgery ]
    The records of the radiation during the surgeries


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575338


Locations
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Spain
Josep Torrent Recruiting
Terrassa, Barcelona, Spain, 07522
Contact: josep torrent, md    +34658425678    jtorrent@mutuaterrassa.es   
Contact    +34658425678    jtorrent@mutuaterrassa.es   
Sponsors and Collaborators
Hospital Mutua de Terrassa
More Information
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Responsible Party: josep torrent, Josep Torrent m.d., Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT03575338    
Other Study ID Numbers: Hospital Mútua Terrassa
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by josep torrent, Hospital Mutua de Terrassa:
scarf
minimally invasive surgery
hallux valgus
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired