Clinical trial NCT05868759: Assessment of Preoperative and Postoperative Ankle Kinematics
Official title: Assessment of Preoperative and Postoperative Ankle Kinematics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: ankle ostearthritis
ankle prosthesis
Roentgen Stereophotogrammetric Analysis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Roentgenstereophotogrammetric analysis
timeFrame: 9 months
Secondary outcomes:
measure: evaluation of range of motion (degree)
timeFrame: at baseline (Day0)
measure: evaluation of range of motion (degree)
timeFrame: 9 months
measure: Delos Postural Proprioceptive System
timeFrame: at baseline (Day0)
measure: Delos Postural Proprioceptive System
timeFrame: 9 months
measure: modified Star Excursional Balance Test (mSEBT) functional test
timeFrame: at baseline (day 0)
measure: modified Star Excursional Balance Test (mSEBT) functional test
timeFrame: 9 months
measure: American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
timeFrame: at baseline (Day0)
measure: American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
timeFrame: 9 months
measure: Short Form Health Survey - 12 questionnaire
timeFrame: at baseline (Day0)
measure: Short Form Health Survey - 12 questionnaire
timeFrame: 9 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
state: BO
Study officials:
References:
citation: 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.
citation: 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.
citation: Gougoulias NE, Khanna A, Maffulli N. History and evolution in total ankle arthroplasty. Br Med Bull. 2009;89:111-51. doi: 10.1093/bmb/ldn039. Epub 2008 Nov 13.
citation: Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.