Total Ankle Arthroplasty SurviviorshipZTM10NCT07732153
Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up
An observational study of Total Ankle Arthroplasty Surviviorship, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Ankle Arthroplasty Surviviorship
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2026to 22 Jul 2026
- How long will I take part?
- 11 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients affected by end-stage ankle osteoarthritis treated with total ankle replacement via a transfibular approach between April 2013 and April 2016 at the Galeazzi Orthopedic Institute in Milan. Follow-up visit data will be collected for the period from January 2013 to April 2026.
Who may be able to join
- Adult patients who underwent total ankle replacement at the IRCCS Galeazzi-Sant'Ambrogio Hospital (formerly Galeazzi Orthopedic Institute) between April 2013 and April 2016 via a transfibular lateral approach with a Zimmer TM prosthesis implant and a minimum follow-up of 10 years
Who cannot join
- Revision joint replacements
- Previous tibiotalar arthrodesis
- Inability to retrieve follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Evaluation of implant survival at a minimum 10-year follow-up and monitoring of any complications and reoperations using the COFAS Reoperation Coding System (CROCS).
- Evaluation of clinical outcomes using:
- AOFAS Questionnaire (Italian version): a specific clinical score for foot and ankle pathologies; despite its limitations, it is used in the majority of similar studies.
- Visual Analog Scale (VAS) for pain assessment to quantify the intensity of pain perceived by the patient.
- Ankle joint Range of Motion (ROM). 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).
- Radiological evaluation using weight-bearing X-rays of the operated ankle (AP, ML, and 20° Saltzman views) taken at 6 months postoperatively and at the latest follow-up. This will allow the evaluation of:
- Aseptic loosening.
- Periprosthetic cyst formation.
- Implant subsidence.
- Heterotopic ossification.
- Osteoarthritis in adjacent joints.
- Any potential correlation between radiological and clinical data will then be evaluated.
- Finally, demographic and biometric parameters of the patients will be recorded (sex, age at the time of surgery, BMI), along with any associated surgical procedures performed concurrently with the total ankle replacement using a transfibular approach.
- Conditions
- Total Ankle Arthroplasty Surviviorship
What is being measured
The primary outcome is the main question the study is designed to answer.
10 years surviviorship of the implants
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start22 Jun 2026
- Primary completion21 Jul 2026
- Study completion22 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Total Ankle Arthroplasty SurviviorshipStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
- Target duration
- 11 Years
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732153
- Sponsor's protocol ID
- CET 198-2026
- Acronym
- ZTM10
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gardini G, Caravelli S, Capodagli C, Vara G, Ratti S, Di Ponte M, Mosca M. Heterotopic ossifications in anterior and lateral approach total ankle replacement: A retrospective evaluation. J Foot Ankle Surg. 2026 Jan-Feb;65(1):15.e1-15.e6. doi: 10.1053/j.jfas.2025.08.001. Epub 2025 Aug 20.
PubMed 40846149Butler JJ, Healy H, Anil U, Habibi A, Azam MT, Walls RJ, Kennedy JG. The significance of heterotopic ossification following total ankle arthroplasty: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol. 2024 May;34(4):1945-1956. doi: 10.1007/s00590-024-03866-1. Epub 2024 Mar 12.
PubMed 38472436Liu X, Zhang H, Li Y, Chen Y, Deng W, Zhang W. Application of Negative Pressure Wound Therapy in Total Ankle Replacement. J Foot Ankle Surg. 2021 Mar-Apr;60(2):283-287. doi: 10.1053/j.jfas.2020.08.021. Epub 2020 Sep 2.
PubMed 33223439Subramanian SA, Kim HN, Kim S, Hwang J, Lee DI, Rhim HC, Kim SJ, Schon L, Sung IH. Long-Term Survival Analysis of 5619 Total Ankle Arthroplasty and Patient Risk Factors for Failure. J Clin Med. 2023 Dec 28;13(1):179. doi: 10.3390/jcm13010179.
PubMed 38202186Mulcahy H, Chew FS. Current Concepts in Total Ankle Replacement for Radiologists: Complications. AJR Am J Roentgenol. 2015 Dec;205(6):1244-50. doi: 10.2214/AJR.14.14171.
PubMed 26587931Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849.
PubMed 12729104Naal FD, Impellizzeri FM, Rippstein PF. Which are the most frequently used outcome instruments in studies on total ankle arthroplasty? Clin Orthop Relat Res. 2010 Mar;468(3):815-26. doi: 10.1007/s11999-009-1036-y. Epub 2009 Aug 12.
PubMed 19672670Younger AS, Glazebrook M, Veljkovic A, Goplen G, Daniels TR, Penner M, Wing KJ, Dryden PJ, Wong H, Lalonde KA. A Coding System for Reoperations Following Total Ankle Replacement and Ankle Arthrodesis. Foot Ankle Int. 2016 Nov;37(11):1157-1164. doi: 10.1177/1071100716659037. Epub 2016 Aug 16.
PubMed 27530987Fletcher AN, Day J, Motsay M, Manchester M, Zhang Z, Schon LC. Transfibular Total Ankle Arthroplasty: Clinical, Functional, and Radiographic Outcomes and Complications at a Minimum of 5-Year Follow-up. Foot Ankle Int. 2025 Jan;46(1):1-8. doi: 10.1177/10711007241290222. Epub 2024 Nov 11.
PubMed 39526761Kim J, Gagne OJ, Rajan L, Caolo K, Sofka C, Ellis SJ, Demetracopoulos CA, Deland JT. Clinical Outcomes of the Lateral Trabecular Metal Total Ankle Replacement at a 5-Year Minimum Follow-up. Foot Ankle Spec. 2023 Jun;16(3):288-299. doi: 10.1177/19386400221139525. Epub 2022 Dec 8.
PubMed 36482702Mosca M, Caravelli S, Vocale E, Maitan N, Grassi A, Massimi S, Fuiano M, Zaffagnini S. Clinical-radiological outcomes and complications after total ankle replacement through a lateral transfibular approach: a retrospective evaluation at a mid-term follow-up. Int Orthop. 2021 Feb;45(2):437-443. doi: 10.1007/s00264-020-04709-4. Epub 2020 Jul 14.
PubMed 32666242Omar IM, Abboud SF, Youngner JM. Imaging of Total Ankle Arthroplasty: Normal Imaging Findings and Hardware Complications. Semin Musculoskelet Radiol. 2019 Apr;23(2):177-194. doi: 10.1055/s-0038-1677466. Epub 2019 Mar 29.
PubMed 30925630Anastasio AT, Lau B, Adams S. Ankle Osteoarthritis. J Am Acad Orthop Surg. 2024 Aug 15;32(16):738-746. doi: 10.5435/JAAOS-D-23-00743. Epub 2024 May 28.
PubMed 38810230Paget LDA, Tol JL, Kerkhoffs GMMJ, Reurink G. Health-Related Quality of Life in Ankle Osteoarthritis: A Case-Control Study. Cartilage. 2021 Dec;13(1_suppl):1438S-1444S. doi: 10.1177/19476035211025814. Epub 2021 Jun 24.
PubMed 34165357Murray C, Marshall M, Rathod T, Bowen CJ, Menz HB, Roddy E. Population prevalence and distribution of ankle pain and symptomatic radiographic ankle osteoarthritis in community dwelling older adults: A systematic review and cross-sectional study. PLoS One. 2018 Apr 30;13(4):e0193662. doi: 10.1371/journal.pone.0193662. eCollection 2018.
PubMed 29708977
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up
- ClinicalTrials.gov ID
- NCT07732153
- Acronym / sponsor ID
- ZTM10 / CET 198-2026
- Conditions
- Total Ankle Arthroplasty Surviviorship
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Evaluation of implant survival at a minimum 10-year follow-up and monitoring of any complications and reoperations using the COFAS Reoperation Coding System (CROCS).
- Evaluation of clinical outcomes using:
- AOFAS Questionnaire (Italian version): a specific clinical score for foot and ankle pathologies; despite its limitations, it is used in the majority of similar studies.
- Visual Analog Scale (VAS) for pain assessment to quantify the intensity of pain perceived by the patient.
- Ankle joint Range of Motion (ROM). 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).
- Radiological evaluation using weight-bearing X-rays of the operated ankle (AP, ML, and 20° Saltzman views) taken at 6 months postoperatively and at the latest follow-up. This will allow the evaluation of:
- Aseptic loosening.
- Periprosthetic cyst formation.
- Implant subsidence.
- Heterotopic ossification.
- Osteoarthritis in adjacent joints.
- Any potential correlation between radiological and clinical data will then be evaluated.
- Finally, demographic and biometric parameters of the patients will be recorded (sex, age at the time of surgery, BMI), along with any associated surgical procedures performed concurrently with the total ankle replacement using a transfibular approach.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 11 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by end-stage ankle osteoarthritis treated with total ankle replacement via a transfibular approach between April 2013 and April 2016 at the Galeazzi Orthopedic Institute in Milan. Follow-up visit data will be collected for the period from January 2013 to April 2026.
Key inclusion criteria (1 listed)
- Adult patients who underwent total ankle replacement at the IRCCS Galeazzi-Sant'Ambrogio Hospital (formerly Galeazzi Orthopedic Institute) between April 2013 and April 2016 via a transfibular lateral approach with a Zimmer TM prosthesis implant and a minimum follow-up of 10 years
Key exclusion criteria (3 listed)
- Revision joint replacements
- Previous tibiotalar arthrodesis
- Inability to retrieve follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
10 years surviviorship of the implants
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 40846149Gardini G, Caravelli S, Capodagli C, Vara G, Ratti S, Di Ponte M, Mosca M. Heterotopic ossifications in anterior and lateral approach total ankle replacement: A retrospective evaluation. J Foot Ankle Surg. 2026 Jan-Feb;65(1):15.e1-15.e6. doi: 10.1053/j.jfas.2025.08.001. Epub 2025 Aug 20.
- Background: PubMed 38472436Butler JJ, Healy H, Anil U, Habibi A, Azam MT, Walls RJ, Kennedy JG. The significance of heterotopic ossification following total ankle arthroplasty: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol. 2024 May;34(4):1945-1956. doi: 10.1007/s00590-024-03866-1. Epub 2024 Mar 12.
- Background: PubMed 33223439Liu X, Zhang H, Li Y, Chen Y, Deng W, Zhang W. Application of Negative Pressure Wound Therapy in Total Ankle Replacement. J Foot Ankle Surg. 2021 Mar-Apr;60(2):283-287. doi: 10.1053/j.jfas.2020.08.021. Epub 2020 Sep 2.
- Background: PubMed 38202186Subramanian SA, Kim HN, Kim S, Hwang J, Lee DI, Rhim HC, Kim SJ, Schon L, Sung IH. Long-Term Survival Analysis of 5619 Total Ankle Arthroplasty and Patient Risk Factors for Failure. J Clin Med. 2023 Dec 28;13(1):179. doi: 10.3390/jcm13010179.
- Background: PubMed 26587931Mulcahy H, Chew FS. Current Concepts in Total Ankle Replacement for Radiologists: Complications. AJR Am J Roentgenol. 2015 Dec;205(6):1244-50. doi: 10.2214/AJR.14.14171.
- Background: PubMed 12729104Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849.
- Background: PubMed 19672670Naal FD, Impellizzeri FM, Rippstein PF. Which are the most frequently used outcome instruments in studies on total ankle arthroplasty? Clin Orthop Relat Res. 2010 Mar;468(3):815-26. doi: 10.1007/s11999-009-1036-y. Epub 2009 Aug 12.
- Background: PubMed 27530987Younger AS, Glazebrook M, Veljkovic A, Goplen G, Daniels TR, Penner M, Wing KJ, Dryden PJ, Wong H, Lalonde KA. A Coding System for Reoperations Following Total Ankle Replacement and Ankle Arthrodesis. Foot Ankle Int. 2016 Nov;37(11):1157-1164. doi: 10.1177/1071100716659037. Epub 2016 Aug 16.
- Background: PubMed 39526761Fletcher AN, Day J, Motsay M, Manchester M, Zhang Z, Schon LC. Transfibular Total Ankle Arthroplasty: Clinical, Functional, and Radiographic Outcomes and Complications at a Minimum of 5-Year Follow-up. Foot Ankle Int. 2025 Jan;46(1):1-8. doi: 10.1177/10711007241290222. Epub 2024 Nov 11.
- Background: PubMed 36482702Kim J, Gagne OJ, Rajan L, Caolo K, Sofka C, Ellis SJ, Demetracopoulos CA, Deland JT. Clinical Outcomes of the Lateral Trabecular Metal Total Ankle Replacement at a 5-Year Minimum Follow-up. Foot Ankle Spec. 2023 Jun;16(3):288-299. doi: 10.1177/19386400221139525. Epub 2022 Dec 8.
- Background: PubMed 32666242Mosca M, Caravelli S, Vocale E, Maitan N, Grassi A, Massimi S, Fuiano M, Zaffagnini S. Clinical-radiological outcomes and complications after total ankle replacement through a lateral transfibular approach: a retrospective evaluation at a mid-term follow-up. Int Orthop. 2021 Feb;45(2):437-443. doi: 10.1007/s00264-020-04709-4. Epub 2020 Jul 14.
- Background: PubMed 30925630Omar IM, Abboud SF, Youngner JM. Imaging of Total Ankle Arthroplasty: Normal Imaging Findings and Hardware Complications. Semin Musculoskelet Radiol. 2019 Apr;23(2):177-194. doi: 10.1055/s-0038-1677466. Epub 2019 Mar 29.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Ankle Arthroplasty Surviviorship, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 years surviviorship of the implants (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07732153, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.