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

NCT07016243 | Recruiting

• 1 other identifier: 0003043-01/03/2025
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Articulation Disorders

Outcome Measures

Primary Outcomes (1)

• Measurement of knee joint range of motion (ROM).

  The study is of a prospective, prognostic, observational nature and involves all patients who are candidates for admission to the Rizzoli Orthopedic Institute for primary knee replacement surgery, recruited in the Orthopedics 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.

  In our study, the joint excursion measurements of the t-t and knee will be taken by the physiotherapists involved in the study with the patient lying in a supine position on a bed, they will be taken pre-operatively (T0) i.e. before the knee arthroplasty

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli Dipartimento Sicilia

Bagheria, Palermo, 900100, Italy

RECRUITING

MeSH Terms

Conditions

Articulation Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Tornatore

  Istituto Ortopedico Rizzoli - Dipartimento Sicilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Tornatore

CONTACT

3331187580; laura.tornatore@ior.it

Davide Raspanti

CONTACT

3293919044; davide.raspanti@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 11, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

IT (1)