CClinicalTrials.gg
RecruitingNCT07016243NODORSIFLEXUpdated Jun 11, 2025

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

An observational study in Articulation Disorders, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
197
Ages
65 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Articulation Disorders
03

In context

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
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.

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
197 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    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

07

Study locations

1 of 1 sites recruiting
  • Istituto Ortopedico Rizzoli Dipartimento Sicilia
    Bagheria, Palermo 900100, Italy
    • Istituto Ortopedico Rizzoli Dipartimento Sicilia · Contact
    • Laura Tornatore · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07016243
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Jun 11, 2025
Start date
Apr 1, 2025
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Jun 11, 2025

Study contacts

Laura Tornatore
Contact
laura.tornatore@ior.it
3331187580
Davide Raspanti
Contact
davide.raspanti@ior.it
3293919044
Laura Tornatore
principal investigator · Istituto Ortopedico Rizzoli - Dipartimento Sicilia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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