Link between limited ankle dorsiflexion and slower knee motion recovery after total knee replacement
Correlation Between Deficits in ROM Recovery of the Knee Operated With PTG and Difficulty in Dorsiflexing the Tibio-tarsal Joint.NODORSIFLEX-IN-PTG
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 type | Observational |
|---|---|
| Enrollment | 197 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bagheria, Palermo) |
| Trial ID | NCT07016243 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bagheria, Palermo
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.