Knee OsteoarthritisGODIVANCT06113549
Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty
A study testing Knee Joint Distraction (KD) and Knee Prosthesis in people with Knee Osteoarthritis, run by UMC Utrecht.
Trial summary
The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Knee Joint Distraction (KD) and Knee Prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jun 2028
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of knee OA
- Age ≤ 65 years and ≥ 18 years
- Persistent, refractory pain, insufficiently responding to conservative or previous surgical therapy
- Structural OA joint damage, indicated by a K\&L grade of at least 2 as determined by the orthopedic surgeon in line with NOV recommendations.
- Able to wear an external fixator and care for it for 6 weeks
- Accepting that the maximal effect of KJD is not present directly after removal of the frame but may take months after frame removal
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- Sufficient joint stability (according to the orthopedic surgeon's judgement)
- Flexion (>100 degrees) and extension range (<10 degrees)
- Weight and BMI <120 kg and <35 kg/m2, respectively
- Sufficient understanding of the Dutch language
- Signed informed consent
Who cannot join
- Surgical intervention in last 6 months
- Leg-axis deviation > 10 degrees (as determined by the orthopedic surgeon)
- Serious osteopenia making placing bone-pins and wearing a frame into a risk (according to the orthopedic surgeon's judgement)
- Coagulation problems making occurrence of thrombosis or embolies into a risk (according to the orthopedic surgeon's judgement)
- Existing endoprosthesis at any other joint (e.g. hip or contralateral knee) to prevent infection of existing prosthesis
- History or presence of joint infection/inflammation
- Hypersensitivity to antibiotics
- Presence of systemic inflammatory disease, like rheumatoid arthritis
About this study
Official title: Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for Young Knee Osteoarthritis Patients in Regular Care
The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA).
The main question[s] it aims to answer are:
Read more
- Is KD non-inferior to KP regarding pain, function and stiffness (as indicated by the total score on the total Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC), with a non-inferiority limit of 15 points) at 2 years?
- Is KD non-inferior to KP regarding Quality of Life (36-Item Short Form Health Survey, (SF36), Physical- and Mental- Component Summary (PCS/MCS), with a non-inferiority limit of 10 points) at 2 years?
- Does KD lead to regeneration of tissue (increase in minimum joint-space-width > 0.05mm on x-ray) over 2 years?
Participants will be allocated to undergo either a knee joint distraction or prosthesis (total- or unicompartmental KP according to orthopedic surgeon/patients discretion), and groups will be compared using will be compared between groups using (multivariable) random effects (mixed) modelling to account for the nested and longitudinal structure of the data over the 24 months follow-up. The stratification factors for randomization, center (using a random intercept) and gender, as well as a limited number of a priori defined prognostic factors (i.e. baseline WOMAC total score, age, BMI, severity of cartilage damage) will be accounted for in this analysis. The difference in mean total WOMAC score at 24 months between treatment groups will be estimated from this model with a 95% confidence interval (CI) and non-inferiority will be determined using the lower limit of this confidence interval.
- Conditions
- Knee Osteoarthritis
- Being tested
- Knee Joint Distraction (KD), Knee Prosthesis
- Keywords
- Knee Osteoarthritis, knee prosthesis indication
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Joint Distraction (KD)Procedure or surgery
Knee joint distraction (KJD) is a joint-preserving treatment for knee OA for younger patients, where the knee joint is temporarily fully unloaded by distraction of tibia and femur, using an external fixation frame.KJD treatment is performed according to the current approved concept NOV recommendations for clinical practice.
Knee ProsthesisProcedure or surgery
A total or unicompartmental knee prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Knee Joint Distraction (KD) | Experimental | Knee joint distraction (KJD) is a joint-preserving treatment for knee OA for younger patients, where the knee joint is temporarily fully unloaded by distraction of tibia and femur, using an external fixation frame. KJD treatment is performed according to the current approved concept NOV recommendations for clinical practice. Receives: Procedure: Knee Joint Distraction (KD) |
| Knee Prosthesis | Active comparator | KP is indicated and surgically implanted according to regular clinical practice (can be a total- or unicompartmental KP, in line with local practice in consultation with the patient and conform the national guideline by Dutch orthopaedic society (NOV)). Receives: Procedure: Knee Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC total Score
Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC) total score (scale 0-100, higher scores indicate improvement), with a non-inferiority limit of 15 points
Measured: at 24 months
Secondary outcomes (1)
Health Related Quality of Life (HRQol)
SF36 physical component score and mental component score (0-100)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paco M.J. Welsing, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113549
- Sponsor's protocol ID
- 22-732/G
- Acronym
- GODIVA
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for Young Knee Osteoarthritis Patients in Regular Care
- ClinicalTrials.gov ID
- NCT06113549
- Acronym / sponsor ID
- GODIVA / 22-732/G
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, knee prosthesis indication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Nov 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.
The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA).
The main question[s] it aims to answer are:
- Is KD non-inferior to KP regarding pain, function and stiffness (as indicated by the total score on the total Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC), with a non-inferiority limit of 15 points) at 2 years?
- Is KD non-inferior to KP regarding Quality of Life (36-Item Short Form Health Survey, (SF36), Physical- and Mental- Component Summary (PCS/MCS), with a non-inferiority limit of 10 points) at 2 years?
- Does KD lead to regeneration of tissue (increase in minimum joint-space-width > 0.05mm on x-ray) over 2 years?
Participants will be allocated to undergo either a knee joint distraction or prosthesis (total- or unicompartmental KP according to orthopedic surgeon/patients discretion), and groups will be compared using will be compared between groups using (multivariable) random effects (mixed) modelling to account for the nested and longitudinal structure of the data over the 24 months follow-up. The stratification factors for randomization, center (using a random intercept) and gender, as well as a limited number of a priori defined prognostic factors (i.e. baseline WOMAC total score, age, BMI, severity of cartilage damage) will be accounted for in this analysis. The difference in mean total WOMAC score at 24 months between treatment groups will be estimated from this model with a 95% confidence interval (CI) and non-inferiority will be determined using the lower limit of this confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Joint Distraction (KD) | Experimental | Procedure: Knee Joint Distraction (KD)Knee joint distraction (KJD) is a joint-preserving treatment for knee OA for younger patients, where the knee joint is temporarily fully unloaded by distraction of tibia and femur, using an external fixation frame. KJD treatment is performed according to the current approved concept NOV recommendations for clinical practice. |
| Knee Prosthesis | Active comparator | Procedure: Knee ProsthesisKP is indicated and surgically implanted according to regular clinical practice (can be a total- or unicompartmental KP, in line with local practice in consultation with the patient and conform the national guideline by Dutch orthopaedic society (NOV)). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical diagnosis of knee OA
- Age ≤ 65 years and ≥ 18 years
- Persistent, refractory pain, insufficiently responding to conservative or previous surgical therapy
- Structural OA joint damage, indicated by a K\&L grade of at least 2 as determined by the orthopedic surgeon in line with NOV recommendations.
- Able to wear an external fixator and care for it for 6 weeks
Key exclusion criteria (8 listed)
- Surgical intervention in last 6 months
- Leg-axis deviation > 10 degrees (as determined by the orthopedic surgeon)
- Serious osteopenia making placing bone-pins and wearing a frame into a risk (according to the orthopedic surgeon's judgement)
- Coagulation problems making occurrence of thrombosis or embolies into a risk (according to the orthopedic surgeon's judgement)
- Existing endoprosthesis at any other joint (e.g. hip or contralateral knee) to prevent infection of existing prosthesis
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 |
|---|---|---|
| Knee Joint Distraction (KD)Knee joint distraction (KJD) is a joint-preserving treatment for knee OA for younger patients, where the knee joint is temporarily fully unloaded by distraction of tibia and femur, using an external fixation frame.KJD treatment is performed according to the current approved concept NOV recommendations for clinical practice. | Procedure or surgery | Knee Joint Distraction (KD) |
| Knee ProsthesisA total or unicompartmental knee prosthesis | Procedure or surgery | Knee Prosthesis |
Primary outcome
WOMAC total Score
Time frame: at 24 months
Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC) total score (scale 0-100, higher scores indicate improvement), with a non-inferiority limit of 15 points
1 secondary outcome
Health Related Quality of Life (HRQol)
Time frame: 24 months
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 7 Nov 2023.
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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?
A study testing Knee Joint Distraction (KD) and Knee Prosthesis in people with Knee Osteoarthritis, run by UMC Utrecht.
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 11 inclusion and 8 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 7 Nov 2023. 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?
WOMAC total Score (time frame: at 24 months). 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 7 Nov 2023.