Correlation Between Deficits in Knee ROM Recovery and Difficulty in Dorsiflexing the Tibio-tarsal Joint in Patients Undergoing Total Knee Replacement Surgery.

NCT ID: NCT07016243

Last Updated: 2025-06-11

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

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-04-01

Brief Summary

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To demonstrate that the deficit in dorsiflexion-tibia-talar joint range of motion can have an effect on the knee operated by arthroplasty by limiting full extension and, in general, the recovery of a full range of motion.

Detailed Description

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The study is of a prospective, prognostic, observational nature and involves all patients who are candidates for admission to the Rizzoli Orthopaedic Institute for primary knee replacement surgery, recruited in the Orthopaedics department and subsequently followed in the Rehabilitation Medicine department of the DRS. The recruited patients will be subjected to pre-operative measurement of the ankle ROM; if they present a limitation of the same, they will be included in the exposed group, alternatively they will be included in the non-exposed group.

Conditions

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Articulation Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients who are candidates for primary total knee replacement surgery aged 65 to 85 years;

Exclusion Criteria

* Patients with known neurological pathologies
* Severe joint deformations such as previous ankle surgery (arthrodesis, ankle prosthesis) congenital malformations (cavus equinus, clubfoot)
* Severe fractures that have compromised the joint
* Traumatic events affecting the lower limb that occurred less than 12 months
* Non-ambulatory patients in the preoperative period
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 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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Responsibility Role SPONSOR

Principal Investigators

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Laura Tornatore

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli - Dipartimento Sicilia

Locations

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Istituto Ortopedico Rizzoli Dipartimento Sicilia

Bagheria, Palermo, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Laura Tornatore

Role: CONTACT

3331187580

Davide Raspanti

Role: CONTACT

3293919044

Facility Contacts

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Istituto Ortopedico Rizzoli Dipartimento Sicilia

Role: primary

Other Identifiers

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0003043-01/03/2025

Identifier Type: -

Identifier Source: org_study_id

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