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NCT Number: NCT07016243

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

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli Dipartimento Sicilia

Bagheria, Palermo, 900100, Italy

Location status: Recruiting

Location contact

Istituto Ortopedico Rizzoli Dipartimento Sicilia

CONTACT

Laura Tornatore

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Raspanti

CONTACT

[email protected]

3293919044

Laura Tornatore

CONTACT

[email protected]

3331187580

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Correlation Between Deficits in ROM Recovery of the Knee Operated With PTG and Difficulty in Dorsiflexing the Tibio-tarsal Joint.NODORSIFLEX-IN-PTG

Acronym: NODORSIFLEX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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