Assessment of Preoperative and Postoperative Ankle Kinema... | NCT05868759

NCT05868759

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients	Experimental	Candidates for an ankle prosthesis	Radiation: Roentgen Stereophotogrammetric Analysis (RSA) Device: Delos Postural Proprioceptive System (computerized oscillating platform) Diagnostic Test: Modified Star Excursional Balance Tests Device: Inertial sensors Xsens MVN Other: American Orthopaedic Foot and Ankle Score (AOFAs) Other: Visual Analogue Scale (VAS) Other: 12-Item Short Form Survey (SF-12)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roentgen Stereophotogrammetric Analysis (RSA)	Radiation	Roentgenstereophotogrammetric analysis (RSA) is a radiographic technique, highly accurate both to evaluate the primary stability of the implant, then the micromovements between bone and implant prosthetic, both for the evaluation of the kinematics of the prosthetic components. The RSA technique in dynamics is able to obtain, with patient in motion, a series of radiographic frames in sequence in two projections, which are captured simultaneously. Each pair of orthogonal projections corresponds to a specific moment of the movement carried out by the patient and will be used to obtain, through dedicated software, a reconstruction three-dimensional instant defined "RSA scenes".

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Roentgenstereophotogrammetric analysis	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	9 months

Measure	Description	Time Frame
evaluation of range of motion (degree)	motion tracker	at baseline (Day0)
evaluation of range of motion (degree)	motion tracker	9 months

Eligibility Module

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;
Clinically documented acute or chronic pathology, other than the indication for the treatment adopted in this Trial, which could affect life expectancy or make it difficult to interpret the outcome of the potential subject in accordance with the Protocol (e.g., renal, hepatic, cardiac, endocrine, haematological, autoimmune, bone metabolism, crystal deposits or neoplasms);
Potential subjects with medical conditions that interfere with the ability to participate in a standardized rehabilitation program;
Participation in any other trial of another drug or experimental device within 60 days prior to the screening visit or administration of that drug or device during the course of this trial.

Facility	Status	City	State	ZIP	Country	Contacts
Rizzoli Orthopaedic Institute		Bologna	BO	40126	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26203850	Result	Riva D, Bianchi R, Rocca F, Mamo C. Proprioceptive Training and Injury Prevention in a Professional Men's Basketball Team: A Six-Year Prospective Study. J Strength Cond Res. 2016 Feb;30(2):461-75. doi: 10.1519/JSC.0000000000001097.
22892416	Result	Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.