Clinical trial NCT04100746: Treatment of Post Traumatic Asymmetrical Ankle Arthritis Using Low Tibial Osteotomy
Official title: Treatment of Post Traumatic Asymmetrical Ankle Arthritis Using Low Tibial Osteotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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 )

Primary outcomes:
measure: AOFAS score
timeFrame: one year
Secondary outcomes:
measure: UNION Rate
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: assiut university orthopedic and traumatology department
name: fasil fahmy adam, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.