NCT03575338

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

June 21, 2018

Last Update Submit

June 29, 2018

Conditions

Hallux Valgus and Bunion (Disorder)

Keywords

scarfminimally invasive surgeryhallux valgus

Outcome Measures

Primary Outcomes (1)

  • Hallux valgus angle postoperative

    The angle among the first metatarsal and the first phalanx

    1 year - 2 years

Secondary Outcomes (4)

  • Intermetatarsal 1-2 angle

    1 year - 2 years

  • First metatarso-phalangeal range of movement

    1 year - 2 years

  • Surgery duration

    Measurement during the surgery

  • Irradiation

    Measurement during the surgery

Study Arms (2)

Open Scarf Osteotomy

ACTIVE COMPARATOR

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

Procedure: Open Scarf Osteotomy

Minimally invasive scarf Osteotomy

EXPERIMENTAL

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

Procedure: Minimally invasive scarf Osteotomy

Interventions

Open Scarf OsteotomyPROCEDURE

Open Scarf Osteotomy

Open Scarf Osteotomy
Minimally invasive scarf OsteotomyPROCEDURE

Minimally invasive scarf Osteotomy

Minimally invasive scarf Osteotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergo hallux valgus surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josep Torrent

Terrassa, Barcelona, 07522, Spain

RECRUITING

MeSH Terms

Conditions

Hallux ValgusBunion

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesFoot Deformities, Acquired

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will not know the technique
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Josep Torrent m.d.

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 2, 2018

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

ES(1)