New treatment option for Ankle Osteoarthritis
Official title Early MOtion Total Ankle Artroplasty
ClinicalTrials.gov ID: NCT06525545
What this study is testing
- What it's testing
- Evaluate the clinical and radiographic results of patients undergoing total ankle arthroplasty and treated in the post-operative period in a randomized manner with early mobilization of the ankle joint or with cast immobilization for 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adult patients (aged between 18 and 80).
- Male or female patients;
- Signature of the informed consent for participation in the study;
- Patients prepared and motivated to comply with the scheduled follow-up visits and the completion of the study questionnaires
You likely can't join if
- main diagnosis other than osteoarthritis, history of ankle infection
- need to carry out surgical interventions associated with total prosthesis ankle (e.g., calcaneal osteotomy, knee lowering osteotomy). first...
- intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol
- peripheral vascular disease
- marked osteoporosis of the ankle and foot
- osteonecrosis of the talus
See the full eligibility criteria
- Adult patients (aged between 18 and 80).
- Male or female patients;
- Signature of the informed consent for participation in the study;
- Patients prepared and motivated to comply with the scheduled follow-up visits and the completion of the study questionnaires
- main diagnosis other than osteoarthritis, history of ankle infection
- need to carry out surgical interventions associated with total prosthesis ankle (e.g., calcaneal osteotomy, knee lowering osteotomy). first metatarsal bone, supramalleolar osteotomy, etc.)
- intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol
- peripheral vascular disease
- marked osteoporosis of the ankle and foot
- osteonecrosis of the talus
- neurological disorders affecting the lower limb inability to understand study information or respond to questionnaires due to cognitive or linguistic deficits
- patients who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.