Comparison of Customized and Standard Total Ankle Prostheses
ConditionAnkle Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorIstituto Ortopedico Rizzoli
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Social conditions (homeless patients, with restrictions on personal freedom)
ASA 3 and 4
Deep venous insufficiency Lower limbs
History of Erisipelas lower limbs
Trial design
Design model
Parallel
Treatments tested in this trial
Total ankle arthroplasty
Procedure/SurgeryPatients 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: TraditionalActive comparator 1 intervention
Group B: CustomExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Ankle radiographic angles
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.
Time frame
at baseline (day 0)2
Ankle radiographic angles
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.
Time frame
3 months3
Ankle radiographic angles
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.
Time frame
6 months4
Ankle radiographic angles
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.
Time frame
12 monthsSecondary outcomes
1
Short form 12
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
Time frame
at baseline (day 0)2
Short form 12
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
Time frame
3 months3
Short form 12
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
Time frame
6 months4
Short form 12
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov