NCT03884907

Brief Summary

This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

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

March 21, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

March 20, 2019

Last Update Submit

March 25, 2019

Conditions

Hallux Valgus

Keywords

human bone graft screwfoot and ankle surgeryhallux valgus deformity

Outcome Measures

Primary Outcomes (8)

  • incidence of surgical revisions

    Was a surgical revision done postoperatively? YES/NO

    1 year

  • incidence of loosening of the screw

    based on x-rays: Is a loosening of the screw visible? YES/NO

    1 year

  • incidence of cracking of the screw

    based on x-rays: Is a cracking of the screw visible? YES/NO

    1 year

  • Hallux valgus angle

    based on x-rays: What ist he Hallux valgus angle? °

    1 year

  • Intermetatarsal angle

    based on x-rays: What is the intermetatarsal angle? °

    1 year

  • incidence of postoperative pseudoarthrosis

    based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO

    1 year

  • evaluation postoperative pain (VAS)

    The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.

    1 year

  • duration of postoperative job-related incapacity

    evaluation of duration

    1 year

Secondary Outcomes (2)

  • Patient satisfaction (VAS)

    1 year

  • Assessment according to the AOFAS score

    1 year

Interventions

The patients will receive human bone graft screws surgicallyPROCEDURE

All patients undergo Hallux valgus correction according to the Austin procedure using human bone graft screws.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from all participating sites scheduled for a Hallux valgus correction using the Austin procedure with human bone graft screws get information about this observational study and have the possibility to participate.

You may qualify if:

  • Indication for the use of a human bone graft in the surgical treatment of Hallux valgus treatment using Austin procedure
  • legal capability of adults
  • Written consent to participation in the study after previous written and oral education
  • Age ≥ 18 years

You may not qualify if:

  • Insufficient knowledge of the German language
  • Alcohol and drug abuse
  • Pregnant or breastfeeding woman
  • Foreseeable compliance issues
  • Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
  • Active osteomyelitis
  • Ulcerations in the area of the skin of the surgical area
  • Revision surgery after primary Hallux valgus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

A.ö. Bezirkskrankenhaus St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, 6380, Austria

RECRUITING

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent surgeon, team member of the foot team

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 21, 2019

Study Start

March 21, 2018

Primary Completion

August 21, 2019

Study Completion

March 21, 2020

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

AU(2)