NCT04100746

Brief Summary

Evaluation of joint preserving procedure for asymmetrical ankle arthritis regarding the improvement of alignment and its effect on symptoms

Trial Health

35
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 Oct 2019

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

First Submitted

Initial submission to the registry

September 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 21, 2019

Last Update Submit

September 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • AOFAS score

    Score measures of pain ,alignment,

    one year

Secondary Outcomes (1)

  • UNION Rate

    6 month

Interventions

surgical intervention by using low tibial osteotomy

Also known as: fibular osteotomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patient with post traumatic ankle arthritis.Age 18-60 years.Symptomatic ankle OA with varus or valgus ankle deformity on X-ray with asymmetrical ankle arthritis.-Patient with clinical symptoms,such as pain with walking and limitation of daily and recreational activities.

You may qualify if:

  • Age 18-60 years. 2-Symptomatic ankle osteoarthritis varus or valgus ankle deformity on X-ray with asymmetrical ankle arthritis.
  • Patient had failure of conservative treatment. 4-Patient with clinical symptoms,such as pain with walking and limitation of daily and recreational activities.

You may not qualify if:

  • End-stage arthritis 2- Severe hindfoot instability that cannot be stabilized 3- Severe vascular or neurologic deficiency in the affected extremity 4 - Neuropathic disorders (eg, Charcot foot). 5- Diabetes,chronic liver disease,renal failure 6- Smoking, and rheumatic disease. 7- Condition altered bone quality (due to medication, large cysts,osteoporosis and osteopenia )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Martin RL, Stewart GW, Conti SF. Posttraumatic ankle arthritis: an update on conservative and surgical management. J Orthop Sports Phys Ther. 2007 May;37(5):253-9. doi: 10.2519/jospt.2007.2404.

    PMID: 17549954BACKGROUND

Study Officials

  • fasil fahmy adam, prof

    assiut university orthopedic and traumatology department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Sayed kamel, physcion

CONTACT

Ahmed Ekram osman, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in assiut university

Study Record Dates

First Submitted

September 21, 2019

First Posted

September 24, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

September 24, 2019

Record last verified: 2019-09