Osteoarthritis, KneeNCT05417984
RSA Restoris MultiCompartmental Knee
An observational study of Osteoarthritis, Knee, run by Reinier Haga Orthopedisch Centrum.
Trial summary
Patients with isolated medial compartment arthritis of the knee are commonly treated with unicompartmental knee arthroplasty (UKA). In contrast with total knee arthroplasty (TKA), UKA shows a higher revision rate, which might be due to implant malpositioning and postoperative malalignment of the lower limb and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Restoris MCK
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will consist of all patients who present at the Reinier Haga Orthopedisch Centrum, require unicompartmental knee prosthesis (UKP) and satisfy the inclusion and exclusion criteria as stated below.
Who may be able to join
- Indication for medial unicompartmental knee replacement as described in the manufacturer's guideline, namely as a result of moderately disabling joint disease of the knee resulting from:
- Painful osteo- or post-traumatic arthritis
- As an alternative to tibial osteotomy
- Age > 18 years
- Patient qualified for UKP based on physical exam and medical history
- Patient is able to speak and write Dutch
- Patient is willing to participate
- Patient is able and willing to provide written informed consent
Who cannot join
- Contraindication as described by the manufacturer:
- Inflammatory arthritis or tricompartmental disease
- Greater than 10 degrees of hyperextension
- Greater than 10 degrees of varus or valgus deformity
- Presence of infection (including history of infection), acute or chronic, local or systematic
- Either mental or neuromuscular disorders that do not allow control of the knee joint
Show all 14Show fewer
- Insufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- Insufficient soft tissue integrity to provide adequate stability
- Insufficient articulation of the hip joint
- Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan
- Insufficient bone quality to provide adequate stability
- Loss of ligament structures to prevent creation of an ideal intra-operative plan
- Patients has a known or suspected sensitivity or allergy to one or more of the implant materials
- Revision UKP surgery of the same compartment
About this study
Official title: Migration of the Restoris MultiCompartmental Knee Implant System in Robotic-assisted Unicompartmental Kneearthroplasty: a 5 Year Follow up RSA Study
Patients with isolated medial compartment arthritis of the knee are commonly treated with unicompartmental knee arthroplasty (UKA). In contrast with total knee arthroplasty (TKA), UKA shows a higher revision rate, which might be due to implant malpositioning and postoperative malalignment of the lower limb and incorrect soft tissue balancing. Nowadays, robotic-assisted UKA is used which improves accurate positioning, optimizes soft-tissue balancing and optimizes radiographic alignment of the implant. The potential benefit could be that this better alignment and positioning results in improved functional outcome and long-term survivorship. As there is a lack in long-term results, more research is needed to the long-term results of robotic-assisted UKA. As long-term results are related to early migration of the implant, investigating the early migration will have additional value to predict the long-term results of robotic-assisted UKA. In this study, we will investigate the early migration of a unicompartmental knee implant (Restoris MultiCompartmental Knee Implant System (Restoris MCK)) used in robotic-assisted UKA using model-based roentgen stereogrammetric analysis (mRSA) and we will relate the migration of this implant to the long-term results of the implant.
The primary objective is to assess the fixation and migration patterns of the Restoris MutliCompartmental Knee Implant System (Stryker) in vivo, using mRSA, over 5 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the Restoris MultiCompartmental Knee Implant System (Stryker) and to relate these to the migration patterns over 5 years.
Read more
A prospective cohort study with 5 years follow-up, in which 33 patients will be enrolled. Patients 18 years or older who require a unicompartmental knee prosthesis as a result of moderately disabling joint disease of the knee will be included. During surgery tantalum markers will be placed to be able to perform mRSA. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years and 5 years.
The main study parameters are the migration of the Restoris MCK of both the tibial and femoral component presented in x-, y- and z-direction. Secondary study parameters are the alignment, survival of the Restoris MCK, clinical scores and radiographic aspects (both x-ray and CT scan).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Restoris MCK
- Keywords
- Unicompartimental knee arthroplasty, Robotic-assisted knee replacement, Migration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoris MCKDevice
During this study the Restoris MCK will be placed using robotic-assisted surgery. At the time of surgery tantalum markers will be placed in the tibia and femur. With these markers migration of the prothesis can be measured over time using RSA radiographs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation along x-, y- and z-axes
The translation of both the tibial and femoral component is expressed in mm and is given in 3 directions, namely along the x-, y- and z-axes.
Measured: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Rotation about x-, y- and z-axes
The rotation of both the tibial and femoral component is expressed in degrees and is given in 3 directions, namely about the x-, y- and z-axes.
Measured: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Secondary outcomes (10)
Survival
Survival of the Restoris MCK is measured by registration of all complications and is expressed by numbers and percentages.
Measured: 5 years after surgery
NRS Pain
The Numeric Pain Rating Scale (NRS) measures the amount of pain experienced in the past week during rest and activity. It is a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
KSS
The Knee Society Score (KSS) is a questionnaire to rate the knee prosthesis function. A high score means a good function and a low score means a worse function. The score varies between 0 and 100.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
ROM
The Range of Motion (ROM) will be measured during the visit. ROM is the capability of a joint to go through its complete spectrum of movements and is expressed in degrees.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
KOOS-PS
The Knee Injury and Osteoarthritis Outcome Score - short version (KOOS-PS) is a questionnaire about the ability to perform normal daily activities. A high score means that the activities cost a lot of effort to perform, while a low score means that the activities can be done with minimum effort. The score varies between 0 and 100.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
OKS
The Oxford Knee Score (OKS) is a questionnaire about the amount of influence of the operated knee on the persons life. A low score means that the life of the person is influenced a lot by the operated knee, while a high score means that the life of the persons is little influenced by the operated knee. The score varies between 0 and 48.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
EQ-5D-5L
The EuroQol-5D-5L (EQ-5D-5L) is a questionnaire that describes the overall health condition of the person. The score is given by an index consisting of 5 numbers, which reprensents a health status.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
FJS
The Forgotten Joint score (FJS) is a questionnaire about the awareness of the prosthetic knee. A high score means a low awareness and a low score means a high awareness. The score varies between 0 and 100.
Measured: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Satisfaction
The satisfaction is a single question about the overall satisfaction of the result of the surgery on a scale from 0 (very unsatisfied) to 10 (very satisfied).
Measured: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Radiographic aspects
Radiographic aspects will be reported and will be described in numbers with percentages.
Measured: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417984
- Sponsor's protocol ID
- NL79250.058.21
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration of the Restoris MultiCompartmental Knee Implant System in Robotic-assisted Unicompartmental Kneearthroplasty: a 5 Year Follow up RSA Study
- ClinicalTrials.gov ID
- NCT05417984
- Acronym / sponsor ID
- NL79250.058.21
- Conditions
- Osteoarthritis, Knee
- Keywords
- Unicompartimental knee arthroplasty, Robotic-assisted knee replacement, Migration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 14 Jun 2022 (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.
Patients with isolated medial compartment arthritis of the knee are commonly treated with unicompartmental knee arthroplasty (UKA). In contrast with total knee arthroplasty (TKA), UKA shows a higher revision rate, which might be due to implant malpositioning and postoperative malalignment of the lower limb and incorrect soft tissue balancing. Nowadays, robotic-assisted UKA is used which improves accurate positioning, optimizes soft-tissue balancing and optimizes radiographic alignment of the implant. The potential benefit could be that this better alignment and positioning results in improved functional outcome and long-term survivorship. As there is a lack in long-term results, more research is needed to the long-term results of robotic-assisted UKA. As long-term results are related to early migration of the implant, investigating the early migration will have additional value to predict the long-term results of robotic-assisted UKA. In this study, we will investigate the early migration of a unicompartmental knee implant (Restoris MultiCompartmental Knee Implant System (Restoris MCK)) used in robotic-assisted UKA using model-based roentgen stereogrammetric analysis (mRSA) and we will relate the migration of this implant to the long-term results of the implant.
The primary objective is to assess the fixation and migration patterns of the Restoris MutliCompartmental Knee Implant System (Stryker) in vivo, using mRSA, over 5 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the Restoris MultiCompartmental Knee Implant System (Stryker) and to relate these to the migration patterns over 5 years.
A prospective cohort study with 5 years follow-up, in which 33 patients will be enrolled. Patients 18 years or older who require a unicompartmental knee prosthesis as a result of moderately disabling joint disease of the knee will be included. During surgery tantalum markers will be placed to be able to perform mRSA. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years and 5 years.
The main study parameters are the migration of the Restoris MCK of both the tibial and femoral component presented in x-, y- and z-direction. Secondary study parameters are the alignment, survival of the Restoris MCK, clinical scores and radiographic aspects (both x-ray and CT scan).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of all patients who present at the Reinier Haga Orthopedisch Centrum, require unicompartmental knee prosthesis (UKP) and satisfy the inclusion and exclusion criteria as stated below.
Key inclusion criteria (8 listed)
- Indication for medial unicompartmental knee replacement as described in the manufacturer's guideline, namely as a result of moderately disabling joint disease of the knee resulting from:
- Age > 18 years
- Patient qualified for UKP based on physical exam and medical history
- Patient is able to speak and write Dutch
- Patient is willing to participate
Key exclusion criteria (14 listed)
- Contraindication as described by the manufacturer:
- Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan
- Insufficient bone quality to provide adequate stability
- Loss of ligament structures to prevent creation of an ideal intra-operative plan
- Patients has a known or suspected sensitivity or allergy to one or more of the implant materials
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 |
|---|---|---|
| Restoris MCKDuring this study the Restoris MCK will be placed using robotic-assisted surgery. At the time of surgery tantalum markers will be placed in the tibia and femur. With these markers migration of the prothesis can be measured over time using RSA radiographs. | Device | – |
Primary outcome
Translation along x-, y- and z-axes
Time frame: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
The translation of both the tibial and femoral component is expressed in mm and is given in 3 directions, namely along the x-, y- and z-axes.
Rotation about x-, y- and z-axes
Time frame: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
The rotation of both the tibial and femoral component is expressed in degrees and is given in 3 directions, namely about the x-, y- and z-axes.
10 secondary outcomes
Survival
Time frame: 5 years after surgery
NRS Pain
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
KSS
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
ROM
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
KOOS-PS
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
OKS
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
EQ-5D-5L
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
FJS
Time frame: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Satisfaction
Time frame: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
Radiographic aspects
Time frame: 5 years after surgery at the following time points: preoperative, 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.
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 14 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Reinier Haga Orthopedisch Centrum.
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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Translation along x-, y- and z-axes (time frame: 5 years after surgery at the following time points: 6 weeks, 6 months, 1 year, 2 years and 5 years postoperative.). 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 14 Jun 2022.