Assessment of Preoperative and Postoperative Ankle Kinematics
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ankle Osteoarthritis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Roentgenstereophotogrammetric analysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective is to study the joint kinematics of the prosthetic implant, in terms of translation, rotation, Range of motion and proprioception, in patients treated for prosthetic replacement of the ankle, quantitatively and under physiological load conditions.
Detailed Description
Patients will be subjected to the same tests at zero time and 9 months after the implantation of the prosthesis, except for RSA which will be performed only 9 months after the surgery.
Investigators
Massimiliano Mosca
Principal Investigator
Istituto Ortopedico Rizzoli
Eligibility Criteria
Inclusion Criteria
- •Candidates for ankle prosthesis
- •Potential party able to provide informed consent and sign the approved Informed Consent Form;
- •Male or female patients aged 40 to 80;
- •Patients available to perform post-operative rehabilitation according to standard protocol, follow-up visits and radiological investigations scheduled for follow-up up up up to 24 months. In addition, patients who are available to perform all study tests, preoperators and follow-up.
Exclusion Criteria
- •Previous total prosthetic replacement of the ankle (revision surgery);
- •Severe pre-operative deformity in valgus or varus (\>10 sanguine); BMI\>40 kg/m2;
- •Pre-existing abnormalities of walking kinematics (amputations, neuro-muscular diseases, polio, hip dysplasia);
- •Severe arthrosis of the knee (Kellgren-Lawrence\>3);
- •Severa coxartrosi (Kellgren-Lawrence\>3);
- •Previous hip and/or knee prosthesis surgery;
- •Total avascular astragalus necrosis or other severe bone loss of the ankle that makes the implantation of standard prosthetic components contraindicated;
- •Pregnancy confirmed by positive hcg serum or in vitro diagnostic test or ongoing breastfeeding;
- •Active or latent infection of the affected ankle joint or any other systemic infection being treated;
- •History of alcoholism, drug or substance abuse intravenously, psychosis, personality disorder/s, poor motivation, emotional or intellectual problems that could make the potential subject unstable for participation in the trial, or any combination of variables which in the opinion of the Principal Investigator should exclude the potential subject;
Outcomes
Primary Outcomes
Roentgenstereophotogrammetric analysis
Time Frame: 9 months
Roentgenstereophotogrammetric analysis (RSA) is a radiographic technique, highly accurate both to assess the primary stability of the implant, and therefore the micromovements between bone and prosthetic implant, and for the evaluation of the kinematics of the prosthetic components. Using reference points it is possible to measure the micro-movements that occur between several contiguous elements
Secondary Outcomes
- modified Star Excursional Balance Test (mSEBT) functional test(9 months)
- evaluation of range of motion (degree)(9 months)
- Delos Postural Proprioceptive System(9 months)
- American Orthopaedic Foot & Ankle score (AOFAs) questionnaire(9 months)
- Short Form Health Survey - 12 questionnaire(9 months)