Ankle OsteoarthritisEMOTAANCT06525545
Early MOtion Total Ankle Artroplasty
A study testing early mobilizzation of the ankle in people with Ankle Osteoarthritis and Ankle - Recurrent Dislocation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Osteoarthritis, Ankle - Recurrent Dislocation, Cartilage Disease
- What is being tested?
- early mobilizzation of the ankle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2023to 31 Oct 2027
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, Italia, 40135
Antonio Mazzotti, MD, PhD, 051 636 6111 ext. +39, antonio.mazzotti@ior.it
051 636 6111 ext. +39
About this study
Official title: Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization
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
- Being tested
- early mobilizzation of the ankle
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mobilizzation of the ankleProcedure or surgery
perform flexion-extension exercises of the operated ankle
| Study group | Role | What they receive |
|---|---|---|
| Mobilizzazione Precoce | Experimental | early motion of the ankle Receives: Procedure: early mobilizzation of the ankle |
| Immobilizzazione Con Stivaletto Gessato | Active comparator | standard treatment Receives: Procedure: early mobilizzation of the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS score
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
MOXFQ
The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
SF-36 Questionnaire o Short Form-36 Health Survey
The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self- erception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental)The scores range from 0 point (best) to 100 (worst).
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
VAS
A Visual Analogue Scale (VAS) is a pain rating scales and ranges from 0 to 10 points
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
STTA - Sagittal TibioTalar Angle
In a lateral weight-bearing radiograph, the saggittal Tibio Talar Angle is the angke between the rantomica axis of the tibia and the he longitudinal axis of the talus, this is determined by drawing a line connecting the midpoints of a line bisecting the talar neck and another line bisecting the talar body
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Hindfoot Alignment - Saltzman view mesurament
On the saltzman radiologial view is calculated thedistance between the axis of the tibia shaft and the contact point of the heel. Normal values -3 ± 7 mm
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Lateral distal tibial angle - LDTA
Lateral distal tibia angle (LDTA) is measured between the mid-diaphyseal line of the tibia and the line parallel to the distal tibial plafond. The lateral distal tibial angle has a norm of 89 degrees ± 3 degrees
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Anterior distal tibial angle - ADTA
The ADTA is formed by the mechanical axis of the tibia and the joint orientation line of the ankle in the sagittal plane and measures 80° ± 3° in the normal lower extremity
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Tibio-Talar Angle - TTA
The tibiotalar angle is between the anatomic axis of the tibia and the superior articular surface of the talar dome. The mean and standard deviation are: 88.7° ± 5.1°
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Center of Rotation of Angulation CORA
The CORA is the intersection of the mid-diaphyseal line and the line starting from the middle of the joint and perpendicular to the abnormal ADTA or LDTA. The CORA can be located at the joint line level (usually due to anatomical joint line malalignment or to ankle degeneration) or proximally (usually due to tibial deformities/fractures).
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Gamma Angle
Gamma angle (γ) is formed by intersection of line drawn through long axis of talar component with line drawn from posterior talar component through middle of talar neck.
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
T-T ratio (Tibio-talar Ratio)
Tibiotalar ratio (TT ratio). A talar reference line is drawn parallel to the floor from the posterior talar point (defined as the intersection between the posterosuperior calcaneal cortex and the posterior subtalar articular surface) to the anterior talar point (vertical projection of the most anterior point of the talus onto the talar reference line). Next, the distal tibial axis is the line drawn between the midpoint of the distal tibial shaft measured 5 and 10 cm above the ankle. This divides the talar reference line into anterior and posterior segments. The TT ratio is the ratio of the length of the posterior segment of the talus (AC) to the longitudinal talar length (AB), expressed as a percentage. Normal value, 27% to 42%
Measured: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start31 Oct 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional randomized case control
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Mazzotti, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525545
- Sponsor's protocol ID
- EMOTAA
- Acronym
- EMOTAA
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hintermann B, Knupp M, Zwicky L, Barg A. Total ankle replacement for treatment of end-stage osteoarthritis in elderly patients. J Aging Res. 2012;2012:345237. doi: 10.1155/2012/345237. Epub 2012 Jun 5.
PubMed 22720158Giannini S, Romagnoli M, O'Connor JJ, Catani F, Nogarin L, Magnan B, Malerba F, Massari L, Guelfi M, Milano L, Volpe A, Rebeccato A, Leardini A. Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles. J Foot Ankle Surg. 2011 Nov-Dec;50(6):641-7. doi: 10.1053/j.jfas.2011.06.003. Epub 2011 Aug 15.
PubMed 21840736Mosca 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 32666242Onggo JR, Nambiar M, Phan K, Hickey B, Galvin M, Bedi H. Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis. Foot Ankle Surg. 2020 Jul;26(5):556-563. doi: 10.1016/j.fas.2019.07.006. Epub 2019 Jul 25.
PubMed 31420116Izzo A, Di Gennaro D, Sgadari A, Coviello A, Marasco D, Balato G, Mariconda M, Bernasconi A. Periprosthetic joint infection in total ankle replacement: which are the current diagnostic criteria? Acta Biomed. 2023 Aug 3;94(4):e2023105. doi: 10.23750/abm.v94i4.14082.
PubMed 37539613
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization
- ClinicalTrials.gov ID
- NCT06525545
- Acronym / sponsor ID
- EMOTAA / EMOTAA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Jul 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventional randomized case control
| Arm | Type | Receives |
|---|---|---|
| Mobilizzazione Precoce | Experimental | Procedure: early mobilizzation of the ankleearly motion of the ankle |
| Immobilizzazione Con Stivaletto Gessato | Active comparator | Procedure: early mobilizzation of the anklestandard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| early mobilizzation of the ankleperform flexion-extension exercises of the operated ankle | Procedure or surgery | Immobilizzazione Con Stivaletto Gessato, Mobilizzazione Precoce |
Primary outcome
AOFAS score
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
MOXFQ
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.
SF-36 Questionnaire o Short Form-36 Health Survey
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self- erception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental)The scores range from 0 point (best) to 100 (worst).
VAS
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
A Visual Analogue Scale (VAS) is a pain rating scales and ranges from 0 to 10 points
STTA - Sagittal TibioTalar Angle
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
In a lateral weight-bearing radiograph, the saggittal Tibio Talar Angle is the angke between the rantomica axis of the tibia and the he longitudinal axis of the talus, this is determined by drawing a line connecting the midpoints of a line bisecting the talar neck and another line bisecting the talar body
Hindfoot Alignment - Saltzman view mesurament
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
On the saltzman radiologial view is calculated thedistance between the axis of the tibia shaft and the contact point of the heel. Normal values -3 ± 7 mm
Lateral distal tibial angle - LDTA
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Lateral distal tibia angle (LDTA) is measured between the mid-diaphyseal line of the tibia and the line parallel to the distal tibial plafond. The lateral distal tibial angle has a norm of 89 degrees ± 3 degrees
Anterior distal tibial angle - ADTA
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The ADTA is formed by the mechanical axis of the tibia and the joint orientation line of the ankle in the sagittal plane and measures 80° ± 3° in the normal lower extremity
Tibio-Talar Angle - TTA
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The tibiotalar angle is between the anatomic axis of the tibia and the superior articular surface of the talar dome. The mean and standard deviation are: 88.7° ± 5.1°
Center of Rotation of Angulation CORA
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
The CORA is the intersection of the mid-diaphyseal line and the line starting from the middle of the joint and perpendicular to the abnormal ADTA or LDTA. The CORA can be located at the joint line level (usually due to anatomical joint line malalignment or to ankle degeneration) or proximally (usually due to tibial deformities/fractures).
Gamma Angle
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Gamma angle (γ) is formed by intersection of line drawn through long axis of talar component with line drawn from posterior talar component through middle of talar neck.
T-T ratio (Tibio-talar Ratio)
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Tibiotalar ratio (TT ratio). A talar reference line is drawn parallel to the floor from the posterior talar point (defined as the intersection between the posterosuperior calcaneal cortex and the posterior subtalar articular surface) to the anterior talar point (vertical projection of the most anterior point of the talus onto the talar reference line). Next, the distal tibial axis is the line drawn between the midpoint of the distal tibial shaft measured 5 and 10 cm above the ankle. This divides the talar reference line into anterior and posterior segments. The TT ratio is the ratio of the length of the posterior segment of the talus (AC) to the longitudinal talar length (AB), expressed as a percentage. Normal value, 27% to 42%
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 2 Aug 2024.
- Background: PubMed 22720158Hintermann B, Knupp M, Zwicky L, Barg A. Total ankle replacement for treatment of end-stage osteoarthritis in elderly patients. J Aging Res. 2012;2012:345237. doi: 10.1155/2012/345237. Epub 2012 Jun 5.
- Background: PubMed 21840736Giannini S, Romagnoli M, O'Connor JJ, Catani F, Nogarin L, Magnan B, Malerba F, Massari L, Guelfi M, Milano L, Volpe A, Rebeccato A, Leardini A. Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles. J Foot Ankle Surg. 2011 Nov-Dec;50(6):641-7. doi: 10.1053/j.jfas.2011.06.003. Epub 2011 Aug 15.
- 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 31420116Onggo JR, Nambiar M, Phan K, Hickey B, Galvin M, Bedi H. Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis. Foot Ankle Surg. 2020 Jul;26(5):556-563. doi: 10.1016/j.fas.2019.07.006. Epub 2019 Jul 25.
- Background: PubMed 37539613Izzo A, Di Gennaro D, Sgadari A, Coviello A, Marasco D, Balato G, Mariconda M, Bernasconi A. Periprosthetic joint infection in total ankle replacement: which are the current diagnostic criteria? Acta Biomed. 2023 Aug 3;94(4):e2023105. doi: 10.23750/abm.v94i4.14082.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early mobilizzation of the ankle in people with Ankle Osteoarthritis and Ankle - Recurrent Dislocation, run by Istituto Ortopedico Rizzoli 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 4 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS score (time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery). The study lists 12 primary outcomes in all. 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 NCT06525545, which also lists 5 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 2 Aug 2024.