Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Ankle radiographic angles
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Ankle radiographic angles
Time Frame: 18 months
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 Outcomes
- Short form 12(18 months)
- Visual Analogic Scale(18 months)
- Ankle Range of motion(18 months)
- American Orthopedic Foot and Ankle Score(18 months)