Gait, UnsteadyNCT03605290
Comparison Between Two Operational Techniques for Total Knee Replacement
A study testing REHAGAIT ANYLIZER in people with Gait, Unsteady and Knee Arthropathy, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%. There are a few operative techniques to perform TKR. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Gait, Unsteady, Knee Arthropathy, Surgery
- What is being tested?
- REHAGAIT ANYLIZER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jun 2018to 1 Jan 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after total knee replacement which was performed in our ward.
Who cannot join
- Less than 6 months have passed after the procedure
- Inability to understand and fill out PROMS questionnaires.
- Inability to walk without aids for at least 20 meters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.
There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.
The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.
- Conditions
- Gait, Unsteady, Knee Arthropathy, Surgery
- Being tested
- REHAGAIT ANYLIZER
- Keywords
- total knee replacement, gait analysis, PROMS, mechanical aligment, kinematic alignment
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REHAGAIT ANYLIZERDiagnostic test
Gait analysis instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Mechanically aligned TKR | Active comparator | patients were operated using the standard mechanically aligned technique Receives: Diagnostic Test: REHAGAIT ANYLIZER |
| Kinematically aligned TKR | Experimental | patients were operated using the newer mechanically aligned technique Receives: Diagnostic Test: REHAGAIT ANYLIZER |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMS
The patients will fill out functionala and quality of life assessment questionnaires
Measured: At least 6 months post operatively
Gait analysis
The patients will perform a gait analysis using the REHAGAIT system.
Measured: At least 6 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start15 Jun 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uriel Giwnewer, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605290
- Sponsor's protocol ID
- 003418EMC
- Status last verified
- Feb 2020
- First submitted
- 18 Jun 2018
- Last updated
- 12 Feb 2020
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
- ClinicalTrials.gov ID
- NCT03605290
- Acronym / sponsor ID
- 003418EMC
- Conditions
- Gait, Unsteady, Knee Arthropathy, Surgery
- Keywords
- total knee replacement, gait analysis, PROMS, mechanical aligment, kinematic alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 30 Jul 2018 (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.
Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.
There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.
The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically aligned TKR | Active comparator | Diagnostic Test: REHAGAIT ANYLIZERpatients were operated using the standard mechanically aligned technique |
| Kinematically aligned TKR | Experimental | Diagnostic Test: REHAGAIT ANYLIZERpatients were operated using the newer mechanically aligned technique |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients after total knee replacement which was performed in our ward.
Key exclusion criteria (3 listed)
- Less than 6 months have passed after the procedure
- Inability to understand and fill out PROMS questionnaires.
- Inability to walk without aids for at least 20 meters.
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 |
|---|---|---|
| REHAGAIT ANYLIZERGait analysis instrumentation | Diagnostic test | Kinematically aligned TKR, Mechanically aligned TKR |
Primary outcome
PROMS
Time frame: At least 6 months post operatively
The patients will fill out functionala and quality of life assessment questionnaires
Gait analysis
Time frame: At least 6 months post operatively
The patients will perform a gait analysis using the REHAGAIT system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REHAGAIT ANYLIZER in people with Gait, Unsteady and Knee Arthropathy, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 12 Feb 2020. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMS (time frame: At least 6 months post operatively). The study lists 2 primary outcomes in all. 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 12 Feb 2020.