Clinical trial NCT06193057: Comparison of Customized and Standard Total Ankle Prostheses
Official title: Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: replacement
customized
TAR
arthroplasty
radiographic angles
clinical scores
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Ankle radiographic angles
timeFrame: at baseline (day 0)
measure: Ankle radiographic angles
timeFrame: 3 months
measure: Ankle radiographic angles
timeFrame: 6 months
measure: Ankle radiographic angles
timeFrame: 12 months
measure: Ankle radiographic angles
timeFrame: 18 months
Secondary outcomes:
measure: Short form 12
timeFrame: at baseline (day 0)
measure: Short form 12
timeFrame: 3 months
measure: Short form 12
timeFrame: 6 months
measure: Short form 12
timeFrame: 12 months
measure: Short form 12
timeFrame: 18 months
measure: Visual Analogic Scale
timeFrame: at baseline (day 0)
measure: Visual Analogic Scale
timeFrame: 3 months
measure: Visual Analogic Scale
timeFrame: 6 months
measure: Visual Analogic Scale
timeFrame: 12 months
measure: Visual Analogic Scale
timeFrame: 18 months
measure: American Orthopedic Foot and Ankle Score
timeFrame: at baseline (day 0)
measure: American Orthopedic Foot and Ankle Score
timeFrame: 3 months
measure: American Orthopedic Foot and Ankle Score
timeFrame: 6 months
measure: American Orthopedic Foot and Ankle Score
timeFrame: 12 months
measure: American Orthopedic Foot and Ankle Score
timeFrame: 18 months
measure: Ankle Range of motion
timeFrame: at baseline (day 0)
measure: Ankle Range of motion
timeFrame: 3 months
measure: Ankle Range of motion
timeFrame: 6 months
measure: Ankle Range of motion
timeFrame: 12 months
measure: Ankle Range of motion
timeFrame: 18 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
state: BO
Study officials:
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