Ankle Osteoarthritis
Conditions
Keywords
replacement, customized, TAR, arthroplasty, radiographic angles, clinical scores
Brief summary
The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures
Interventions
PROCEDURETotal ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement. * Consenting patients and able to complete scheduled study procedures and follow-up evaluations. * Patients who have signed the informed consent approved by the Ethics Committee.
Exclusion criteria
* Social conditions (homeless patients, with restrictions on personal freedom) * ASA 3 and 4 * Deep venous insufficiency Lower limbs * History of Erisipelas lower limbs * Neurological or psychocognitive disorders * neurological diseases * Axial deformities of ankle \>15° * Personal or family history of DVT or EP * Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis) * Pregnant women * Patients with rheumatic diseases * Patients that requires ancillary surgical procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle radiographic angles | at baseline (day 0) | Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short form 12 | at baseline (day 0) | The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life. |
| Visual Analogic Scale | at baseline (day 0) | Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks. |
| American Orthopedic Foot and Ankle Score | at baseline (day 0) | This Score, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex. |
| Ankle Range of motion | at baseline (day 0) | Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°. |
Countries
Italy
Contacts
Primary Contactmassimiliano mosca, MD
Backup Contactsilvio caravelli, MD
Outcome results
None listed