Total Knee ArtroplastyNCT05751954
Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty
A study testing Postero-anterior weight-bearing full-leg radiograph and Pedobarographic analysis in people with Total Knee Artroplasty, run by Clinic for Orthopedics Lovran at 1 site in Croatia.
Trial summary
This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Artroplasty
- What is being tested?
- Postero-anterior weight-bearing full-leg radiograph and Pedobarographic analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Aug 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- knee varus or valgus deformity 5 degrees or more
Who cannot join
- previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinic for Orthopeadics and Traumatology Lovran
Lovran, Primorje-Gorski Kotar County, 51145
Tomislav Prpic, PhD, MD, +38598461143, tomislav.prpic317@gmail.com
Antea Buterin, MD
About this study
This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. In addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. The practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). Our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (AOFAS, KOOS) preoperatively, and at the screening three months postoperatively.
- Conditions
- Total Knee Artroplasty
- Being tested
- Postero-anterior weight-bearing full-leg radiograph, Pedobarographic analysis
- Keywords
- weight-bearing mechanical axis, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postero-anterior weight-bearing full-leg radiographRadiation
Full leg standing X ray of the involved lower extremity (postero-anterior direction)
Pedobarographic analysisDevice
Foot pressure analysis during gait on pedobarographic device
| Study group | Role | What they receive |
|---|---|---|
| Arm Label | Other | All patients who undergo total knee arthroplasty and met inclusion and exclusion criteria Receives: Radiation: Postero-anterior weight-bearing full-leg radiograph; Device: Pedobarographic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing mechanical axis
Measured: 1 year
Secondary outcomes (1)
Pedobarographic analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Aug 2019
- Primary completion20 Feb 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArtroplastyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinic for Orthopedics Lovran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antea Buterin, Clinic for Orthopedics Lovran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751954
- Sponsor's protocol ID
- MEH01
- Status last verified
- Feb 2023
- First submitted
- 31 Aug 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05751954
- Acronym / sponsor ID
- MEH01
- Conditions
- Total Knee Artroplasty
- Keywords
- weight-bearing mechanical axis, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinic for Orthopedics LovranUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. In addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. The practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). Our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (AOFAS, KOOS) preoperatively, and at the screening three months postoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Label | Other | Radiation: Postero-anterior weight-bearing full-leg radiograph, Device: Pedobarographic analysisAll patients who undergo total knee arthroplasty and met inclusion and exclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- knee varus or valgus deformity 5 degrees or more
Key exclusion criteria (1 listed)
- previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postero-anterior weight-bearing full-leg radiographFull leg standing X ray of the involved lower extremity (postero-anterior direction) | Radiation | Arm Label |
| Pedobarographic analysisFoot pressure analysis during gait on pedobarographic device | Device | Arm Label |
Primary outcome
Weight-bearing mechanical axis
Time frame: 1 year
1 secondary outcome
Pedobarographic analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postero-anterior weight-bearing full-leg radiograph and Pedobarographic analysis in people with Total Knee Artroplasty, run by Clinic for Orthopedics Lovran at 1 site in Croatia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antea Buterin, MD (+395911978453, antea.buterin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-bearing mechanical axis (time frame: 1 year). 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 2 Mar 2023.