Osteo Arthritis KneeK-ModNCT04524312
Dynamic Congruence Total Knee Replacement vs Posterior-stabilized
A study testing Total knee replacement, Biomechanics and NexGen Ps or Bioimplanti K-MOD implant in people with Osteo Arthritis Knee and Surgery, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteo Arthritis Knee, Surgery, Joint Diseases
- What is being tested?
- Total knee replacement, Biomechanics and NexGen Ps or Bioimplanti K-MOD implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2017to 26 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- agreement to participate in the study
- BMI (kg/m2) less than 40
- ability to walk for 10 meters
- knee flexion more or equal of 90 degrees
Who cannot join
- unwillingness to participate in the study
- osteoarthritis due to the rheumatological disease
- disorders associated with nerve-muscle signal transmission
- neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 03-984
About this study
Official title: Does Dynamic Congruence Design Improve Gait After Total Knee Replacement in Comparison to Posterior-stabilized One? - Prospective Randomized Controlled Trial
This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence
Read the detailed description
The aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (PS) or dynamic congruence (DC) implants.
Materials and methods To this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and VAS (Visual Analogue Scale).
After the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of BTS SMART device. This device uses passive markers technology and registers the movement by six cameras. To perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). Whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the Davis protocol. Markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the V metatarsal bone).
Participants will walk barefoot for 10 meters quadruple times. Following time-space and kinematic parameters will be assessed:
Time-space parameters Single stance time (T1) [%] Swing time (T2) [%] Double-stance time (T3) [%] Step length (SL) [m] Mean gait velocity (Vm) [m/s] Cadence (C) [number of steps/min]
Kinematic parameters:
Operated knee range of flexion during swing phase [°]
- Conditions
- Osteo Arthritis Knee, Surgery, Joint Diseases
- Being tested
- Total knee replacement, Biomechanics, NexGen Ps or Bioimplanti K-MOD implant
- Keywords
- osteoarthritis, knee, congruence, posterior-stabilized, cruciate-retaining
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacementProcedure or surgery
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant
BiomechanicsDiagnostic test
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
NexGen Ps or Bioimplanti K-MOD implantDevice
Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| NexGen | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis Receives: Procedure: Total knee replacement; Diagnostic Test: Biomechanics; Device: NexGen Ps or Bioimplanti K-MOD implant |
| K-Mod | Active comparator | Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Bioimplanti K-MOD prosthesis Receives: Procedure: Total knee replacement; Diagnostic Test: Biomechanics; Device: NexGen Ps or Bioimplanti K-MOD implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of swing phase
Change from baseline part of swing phase time during gait, measured in percentage
Change from baseline part of swing phase time during gait, measured in percentage
Measured: Time Frame: 1-3 years after surgery
Time of stance phase
Change from baseline part of stance phase time during gait, measured in percentage
Measured: Time Frame: 1-3 years after surgery
Time of double-stance phase
Change from baseline part of double-stance phase time during gait, measured in percentage
Measured: Time Frame: 1-3 years after surgery
Stride length
Change from baseline length of stride during gait, measured in meters
Measured: Time Frame: 1-3 years after surgery
Cadence
Change from baseline number of strides per minute of walking
Measured: Time Frame: 1-3 years after surgery
Mean gait velocity
Change from baseline mean values of gait speed, measured in meters per second
Measured: Time Frame: 1-3 years after surgery
Range of maximal hip extension for both limbs during ending part of mid-stance phase
Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees
Measured: Time Frame: 1-3 years after surgery
Range of pelvic drop in frontal plane on the opposite site of the bearing limb
Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees
Measured: Time Frame: 1-3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Dec 2017
- Primary completion26 Sep 2020
- Study completion26 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Bartosz M. Maciąg, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524312
- Sponsor's protocol ID
- WarsawMU/kmod
- Acronym
- K-Mod
- Status last verified
- Sep 2020
- First submitted
- 19 Aug 2020
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dynamic Congruence Design Improve Gait After Total Knee Replacement in Comparison to Posterior-stabilized One? - Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04524312
- Acronym / sponsor ID
- K-Mod / WarsawMU/kmod
- Conditions
- Osteo Arthritis Knee, Surgery, Joint Diseases
- Keywords
- osteoarthritis, knee, congruence, posterior-stabilized, cruciate-retaining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 24 Aug 2020 (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 study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence
Detailed description
The aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (PS) or dynamic congruence (DC) implants.
Materials and methods To this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and VAS (Visual Analogue Scale).
After the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of BTS SMART device. This device uses passive markers technology and registers the movement by six cameras. To perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). Whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the Davis protocol. Markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the V metatarsal bone).
Participants will walk barefoot for 10 meters quadruple times. Following time-space and kinematic parameters will be assessed:
Time-space parameters Single stance time (T1) [%] Swing time (T2) [%] Double-stance time (T3) [%] Step length (SL) [m] Mean gait velocity (Vm) [m/s] Cadence (C) [number of steps/min]
Kinematic parameters:
Operated knee range of flexion during swing phase [°]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NexGen | Active comparator | Procedure: Total knee replacement, Diagnostic Test: Biomechanics, Device: NexGen Ps or Bioimplanti K-MOD implantPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis |
| K-Mod | Active comparator | Procedure: Total knee replacement, Diagnostic Test: Biomechanics, Device: NexGen Ps or Bioimplanti K-MOD implantPatients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Bioimplanti K-MOD prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- agreement to participate in the study
- BMI (kg/m2) less than 40
- ability to walk for 10 meters
- knee flexion more or equal of 90 degrees
Key exclusion criteria (4 listed)
- unwillingness to participate in the study
- osteoarthritis due to the rheumatological disease
- disorders associated with nerve-muscle signal transmission
- neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity
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 |
|---|---|---|
| Total knee replacementParticipant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant | Procedure or surgery | K-Mod, NexGen |
| BiomechanicsParticipants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively | Diagnostic test | K-Mod, NexGen |
| NexGen Ps or Bioimplanti K-MOD implantParticipant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis. | Device | K-Mod, NexGen |
Primary outcome
Time of swing phase
Time frame: Time Frame: 1-3 years after surgery
Change from baseline part of swing phase time during gait, measured in percentage Change from baseline part of swing phase time during gait, measured in percentage
Time of stance phase
Time frame: Time Frame: 1-3 years after surgery
Change from baseline part of stance phase time during gait, measured in percentage
Time of double-stance phase
Time frame: Time Frame: 1-3 years after surgery
Change from baseline part of double-stance phase time during gait, measured in percentage
Stride length
Time frame: Time Frame: 1-3 years after surgery
Change from baseline length of stride during gait, measured in meters
Cadence
Time frame: Time Frame: 1-3 years after surgery
Change from baseline number of strides per minute of walking
Mean gait velocity
Time frame: Time Frame: 1-3 years after surgery
Change from baseline mean values of gait speed, measured in meters per second
Range of maximal hip extension for both limbs during ending part of mid-stance phase
Time frame: Time Frame: 1-3 years after surgery
Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees
Range of pelvic drop in frontal plane on the opposite site of the bearing limb
Time frame: Time Frame: 1-3 years after surgery
Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees
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 29 Sep 2020.
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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.
Bartosz M. Maciąg, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement, Biomechanics and NexGen Ps or Bioimplanti K-MOD implant in people with Osteo Arthritis Knee and Surgery, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 4 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 29 Sep 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 Poland. 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?
Time of swing phase (time frame: Time Frame: 1-3 years after surgery). The study lists 8 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 29 Sep 2020.