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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04100746
Other study ID # ankle osteoarthritis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 2021

Study information

Verified date September 2019
Source Assiut University
Contact Mohamed Sayed kamel, physcion
Phone 01020338353
Email Mskalmaystro72@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date October 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
supramalleolar osteotomy
surgical intervention by using low tibial osteotomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary AOFAS score Score measures of pain ,alignment, one year
Secondary UNION Rate union rate of supramalleolar osteotomy 6 month
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