Ankle OsteoarthritisNCT03356951
Gait Analysis Following Total Ankle Replacement and Subtalar Fusion
An observational study of Ankle Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- TAR through anterior approach and subtalar fusion and TAR through lateral approach and subtalar fusion
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2017to 29 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent simoultanous total ankle replacement and subtalar fusion
Who may be able to join
- Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee
- Males or females aged between 20 and 80 years old.
- Patients with diagnosis of primary not-inflammatory degenerative articular disease
Who cannot join
- Patients with Body Mass Index (BMI)> 35.
- Patients with active or suspected latent periprosthetic infection
- Patients who underwent revision surgery.
- Prosthesis of the hip, knee or ankle, homolateral or contralateral.
- Fusion failure of subtalar joint.
- Patients with chronic heart failure (NYHA stage> 2)
Show all 9Show fewer
- Presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies
- Cognitive deficits.
- Impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.
Read the detailed description
Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.
- Conditions
- Ankle Osteoarthritis
- Being tested
- TAR through anterior approach and subtalar fusion, TAR through lateral approach and subtalar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAR through anterior approach and subtalar fusionProcedure or surgery
Also called Hintegra ankle system
Simultaneous total ankle replacement through anterior approach and subtalar fusion
TAR through lateral approach and subtalar fusionProcedure or surgery
Also called Zimmer TM (Trabecular Metal ) Total Ankle
Simultaneous total ankle replacement through lateral approach and subtalar fusion
| Study group | Role | What they receive |
|---|---|---|
| Lateral approach group | TAR through lateral approach and subtalar fusion Receives: Procedure: TAR through lateral approach and subtalar fusion | |
| Anterior approach group | TAR through anterior approach and subtalar fusion Receives: Procedure: TAR through anterior approach and subtalar fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs
Measured: 1 day
Secondary outcomes (3)
VAS (Visual Analog Scale)
Differences in Pain Scores on the Visual Analog Scale
Measured: 1 day
AOFAS
Differences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score
Measured: 1 day
Short Form Health Survey (SF-12)
Differences in Health Scores on the 12-Item Short Form Health Survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start16 Mar 2017
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
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
- NCT03356951
- Sponsor's protocol ID
- MAT
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Usuelli FG, Indino C, Leardini A, Manzi L, Ortolani M, Caravaggi P. Range of motion of foot joints following total ankle replacement and subtalar fusion. Foot Ankle Surg. 2021 Feb;27(2):150-155. doi: 10.1016/j.fas.2020.03.015. Epub 2020 Apr 27.
PubMed 32381452
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT03356951
- Acronym / sponsor ID
- MAT
- Conditions
- Ankle Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 29 Nov 2017 (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.
Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.
Detailed description
Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral approach group | – | Procedure: TAR through lateral approach and subtalar fusionTAR through lateral approach and subtalar fusion |
| Anterior approach group | – | Procedure: TAR through anterior approach and subtalar fusionTAR through anterior approach and subtalar fusion |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent simoultanous total ankle replacement and subtalar fusion
Key inclusion criteria (3 listed)
- Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee
- Males or females aged between 20 and 80 years old.
- Patients with diagnosis of primary not-inflammatory degenerative articular disease
Key exclusion criteria (9 listed)
- Patients with Body Mass Index (BMI)> 35.
- Patients with active or suspected latent periprosthetic infection
- Patients who underwent revision surgery.
- Prosthesis of the hip, knee or ankle, homolateral or contralateral.
- Fusion failure of subtalar joint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAR through anterior approach and subtalar fusionAlso: Hintegra ankle systemSimultaneous total ankle replacement through anterior approach and subtalar fusion | Procedure or surgery | Anterior approach group |
| TAR through lateral approach and subtalar fusionAlso: Zimmer TM (Trabecular Metal ) Total AnkleSimultaneous total ankle replacement through lateral approach and subtalar fusion | Procedure or surgery | Lateral approach group |
Primary outcome
Gait analysis
Time frame: 1 day
Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs
3 secondary outcomes
VAS (Visual Analog Scale)
Time frame: 1 day
AOFAS
Time frame: 1 day
Short Form Health Survey (SF-12)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Derived from this study: PubMed 32381452Usuelli FG, Indino C, Leardini A, Manzi L, Ortolani M, Caravaggi P. Range of motion of foot joints following total ankle replacement and subtalar fusion. Foot Ankle Surg. 2021 Feb;27(2):150-155. doi: 10.1016/j.fas.2020.03.015. Epub 2020 Apr 27.
Related trials for Ankle Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Not yet recruitingObservational study
Diagnostic Accuracy of Triphasic Bone Scan and SPECT/CT in Foot and Ankle Osteoarthritis
Osteoarthritis, Foot Osteoarthritis
Active, not recruitingObservational study
UK Infinity, Post-Market Clinical Follow-up Study
Arthritis, Rheumatoid, Post-traumatic Osteoarthritis
Active, not recruiting
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
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 Ankle Osteoarthritis, 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 4 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gait analysis (time frame: 1 day). 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 NCT03356951, which also lists 1 linked publication.
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 4 Dec 2017.