- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100746
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.
Sponsor
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.
Clinical Trials on Ankle Arthritis
-
Orthopaedic Associates of Michigan, PCCompletedRheumatoid Arthritis of Ankle | Osteoarthritis of Ankle | Traumatic Arthritis of AnkleUnited States
-
Istituto Ortopedico RizzoliRecruitingArthrosis | Ankle Arthritis | Ankle ReplacementItaly
-
University Medical Centre LjubljanaUnknownInstability; Ankle (Ligaments) (Old Injury) | Ankle Arthritis | Osteochondral Lesion of Talus | Impingement Syndrome of AnkleSlovenia
-
Integrant Pty LtdUniversity of Technology, SydneyNot yet recruitingArthritis Knee | Arthritis AnkleAustralia
-
MedShape, IncOrthopedic Foot and Ankle Center, Ohio; CurveBeam LLCRecruitingAnkle Arthritis | Arthritis FootUnited States
-
Nova Scotia Health AuthorityJohnson & Johnson; Canadian Orthopaedic Foot and Ankle SocietyActive, not recruiting
-
Unity Health TorontoUnknown
-
Columbia Orthopaedic Group, LLPTerminated
-
Unity Health TorontoJohnson & JohnsonUnknown
-
MedShape, IncUniversity of Alabama at BirminghamRecruitingAnkle Arthritis | Foot ArthritisUnited States
Clinical Trials on supramalleolar osteotomy
-
University of MichiganCompleted
-
University of Puget SoundCompleted
-
Istanbul UniversityRecruitingDevelopmental Dysplasia of the Hip | Acetabular Dysplasia | Developmental Dysplasia of the Hip (DDH)Turkey (Türkiye)
-
Hawler Medical UniversityRecruiting
-
He Jin PengWuhan Union Hospital, China; Hunan Children's Hospital; Guangzhou Women and Children... and other collaboratorsUnknownFemur Head Necrosis | Hip Dislocation
-
Chang Gung Memorial HospitalUnknownCleft Lip and Palate | Le FortTaiwan
-
University Hospital, Basel, SwitzerlandCompletedKnee OsteoarthritisSwitzerland
-
Hams Hamed AbdelrahmanCompleted
-
Sercan KüçükkurtCompletedDental Implant Surgery | Osteotomy ProtocolsTurkey (Türkiye)
-
University of MosulEnrolling by invitationDental Implant | Alveolar Bone Loss | Osseodensification Drilling TechniqueIraq