Articulation DisordersNODORSIFLEXNCT07016243
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 of Articulation Disorders, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Articulation Disorders
- How many people
- 197 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli Dipartimento Sicilia
Bagheria, Palermo, 900100
Istituto Ortopedico Rizzoli Dipartimento Sicilia
Laura Tornatore
About this study
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
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.
- Conditions
- Articulation Disorders
- Medical subject headings
- Articulation Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articulation DisordersStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Tornatore, Principal investigator, Istituto Ortopedico Rizzoli - Dipartimento Sicilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016243
- Sponsor's protocol ID
- 0003043-01/03/2025
- Acronym
- NODORSIFLEX
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07016243
- Acronym / sponsor ID
- NODORSIFLEX / 0003043-01/03/2025
- Conditions
- Articulation Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Tornatore principal investigator
Istituto Ortopedico Rizzoli - Dipartimento Sicilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Articulation Disorders, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Tornatore (3331187580, laura.tornatore@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.