Early MOtion Total Ankle Artroplasty

NCT ID: NCT06525545

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2027-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Ankle Osteoarthritis Ankle - Recurrent Dislocation Cartilage Disease Ankle Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

interventional randomized case control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobilizzazione Precoce

early motion of the ankle

Group Type EXPERIMENTAL

early mobilizzation of the ankle

Intervention Type PROCEDURE

perform flexion-extension exercises of the operated ankle

Immobilizzazione Con Stivaletto Gessato

standard treatment

Group Type ACTIVE_COMPARATOR

early mobilizzation of the ankle

Intervention Type PROCEDURE

perform flexion-extension exercises of the operated ankle

Interventions

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early mobilizzation of the ankle

perform flexion-extension exercises of the operated ankle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Antonio Mazzotti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, Italia, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Antonio Mazzotti, MD, PhD

Role: primary

051 636 6111 ext. +39

Role: backup

051 636 6111 ext. +39

References

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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.

Reference Type BACKGROUND
PMID: 22720158 (View on PubMed)

Giannini 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.

Reference Type BACKGROUND
PMID: 21840736 (View on PubMed)

Mosca 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.

Reference Type BACKGROUND
PMID: 32666242 (View on PubMed)

Onggo 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.

Reference Type BACKGROUND
PMID: 31420116 (View on PubMed)

Izzo 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.

Reference Type BACKGROUND
PMID: 37539613 (View on PubMed)

Other Identifiers

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EMOTAA

Identifier Type: -

Identifier Source: org_study_id

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