Treatment of Post Traumatic Asymmetrical Ankle Arthritis Using Low Tibial Osteotomy

September 21, 2019 updated by: Mohamed sayed kamel, Assiut University
Evaluation of joint preserving procedure for asymmetrical ankle arthritis regarding the improvement of alignment and its effect on symptoms

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The most common cause of end-stage ankle arthritis is trauma. Post traumatic ankle arthritis is accepted as the most common cause of ankle arthritis,with reports ranging from 70% to 80% of all ankle arthritis. Factors contributing to the development of posttraumatic ankle arthritis are the initial cartilage damage, malreduction ,nonunion, infections, and instability. In a retrospective study,found that 55% of patients with posttraumatic ankle arthritis presented with a varus malalignment, whereas 8% had valgus malalignment 1. Nonoperative treatments, including orthotics, wedges, shoe modifications,anti-inflammatory medications, and activity modification,are usually not successful. Although the gold standard treatment for ankle arthrosis remains ankle arthrodesis, the significant loss of motion in the ankle is limiting and may lead to the development of arthritis in adjacent joints in the hind foot and forefoot . Total ankle replacements (TAR) used only in older, low-demand patients with neutral alignment and intact stabilizing ligaments. Ankle arthroscopy is indicated in acute, recurring-acute, and chronic ankle pain to detect the possible presence of anterior ankle impingement (bony or soft tissue), syndesmotic injury, osteochondral defects and loose bodies . Supramalleolar osteotomy have been used for varus and valgus as well as sagittal and rotational deformities .Fibular osteotomy, Calcaneal slide osteotomy and osteotomies of the medial arch can be also used as joint preserving procedure. Our study is designed for evaluation of the effect of joint preserving procedures in young patient with asymmetrical ankle arthritis.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 1-Age 18-60 years. 2-Symptomatic ankle osteoarthritis varus or valgus ankle deformity on X-ray with asymmetrical ankle arthritis.

    3-Patient had failure of conservative treatment. 4-Patient with clinical symptoms,such as pain with walking and limitation of daily and recreational activities.

Exclusion Criteria:

  • 1- 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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS score
Time Frame: one year
Score measures of pain ,alignment,
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UNION Rate
Time Frame: 6 month
union rate of supramalleolar osteotomy
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: fasil fahmy adam, prof, assiut university orthopedic and traumatology department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

September 21, 2019

First Submitted That Met QC Criteria

September 21, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 21, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ankle osteoarthritis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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