IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, 20100, Italy
NCT Number: NCT07732153
Ankle osteoarthritis is a disabling condition that can significantly impair patients' quality of life. Ankle arthrodesis has historically represented the gold standard for treating this condition [2], but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term literature data are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.
This study is active but is not currently recruiting participants.
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Observational
Milan, 20100, Italy
Ankle osteoarthritis is a disabling condition that can significantly impair the quality of life of affected patients. Ankle arthrodesis has historically represented the gold standard for treating this condition, but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term data in the literature are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.
The objective of the present study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle replacements.
The protocol involves the collection of clinical and radiological data analyzed over the years during outpatient evaluations. Specifically, the evaluations are structured as follows:
All the above data will be collected at two follow-up time points: immediately preoperatively and at the latest follow-up visit (at least 10 years after surgery).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 years
The objective of this study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle prostheses implanted via a transfibular approach.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Other
Acronym: ZTM10
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