Clinical trial Recruiting at 1 site Observational Ages 65 to 85

Link between limited ankle dorsiflexion and slower knee motion recovery after total knee replacement

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

Run by Istituto Ortopedico Rizzoli · NCT07016243 · Data updated 2026-11-12

This study will see if people aged 65–85 with limited ankle dorsiflexion have more trouble regaining full knee motion after a primary total knee replacement.

Quick facts

Study typeObservational
Ages65 Years to 85 Years
SexAll
Enrollment197 (estimated)
SponsorIstituto Ortopedico Rizzoli
Academic / other
Locations1 site (Bagheria, Palermo)
StatusRecruiting
StartedApril 1, 2025
Main results expectedApril 1, 2027
Study endsApril 1, 2027
Registry record updatedJune 11, 2025
Trial IDNCT07016243 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are consenting patients aged 65–85 scheduled for primary total knee replacement who are ambulatory preoperatively and do not have major neurological disease or severe ankle deformity.

Probably not a fit

Patients with prior ankle arthrodesis or prosthesis, congenital ankle malformations, recent major lower-limb trauma, severe joint destruction, or non-ambulatory status are excluded and would not be represented by the study results.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, prognostic, observational study enrolling patients scheduled for primary total knee replacement at the Istituto Ortopedico Rizzoli in Bagheria (Palermo). Participants receive a preoperative measurement of tibio-talar (ankle) dorsiflexion and are grouped as exposed (limited dorsiflexion) or non-exposed. Knee range-of-motion recovery is then followed in the Rehabilitation Medicine department after surgery to compare outcomes between groups. Patients with neurological disease, severe ankle deformities or prior major ankle surgery, recent lower-limb trauma, or who are non-ambulatory are excluded.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at higher risk of poor knee ROM recovery and target pre- or postoperative rehabilitation to improve outcomes.

How similar studies have gone: Prior studies have suggested relationships between ankle mobility and knee function, but prospective data specifically linking preoperative tibio-talar dorsiflexion to postoperative knee ROM recovery after total knee replacement remain limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Istituto Ortopedico Rizzoli Dipartimento Sicilia
    Bagheria, Palermo, Italy
    Recruiting

Study contacts

  • Principal investigator: Laura Tornatore — Istituto Ortopedico Rizzoli - Dipartimento Sicilia
  • Study coordinator: Laura Tornatore
  • Email: laura.tornatore@ior.it
  • Phone: 3331187580

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.