Osteoarthritis, KneeNEONCT03884049
Neovascularization Embolisation for Knee Osteoarthritis.(NEO)
A study testing Embolization in people with Osteoarthritis, Knee, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization. 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?
- Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jun 2019to 30 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age.≥18 years
- Knee pain for a duration of ≥ 6 months
- Knee pain (numeric rating scale ≥4 - ≤8) on at least half of the days in the preceding month at time of inclusion.
- There is insufficient response of conservative treatment for at least 6 months
- Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)
- Exlusion criteria:
Show all 19Show fewer
- Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
- Contra-indications for angiography
- Renal insufficiency, checked with blood sample test (GFR < 30 ml/min/1, 73 m2);
- Known allergy to contrast agents;
- Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
- Women who are pregnant or lactating
- Intermittent claudication of affected limb
- Intra articular injections in the ipsilateral knee less than 6 months ago
- On the waiting list for joint replacement surgery
- Amitriptyline usage.
- Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene.
- Insufficient command of the Dutch or English language.
- Legally incompetent adults.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.
Read the detailed description
Rationale:
Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.
A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction
Objective:
The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.
The investigators hypothesize that novel transcatheter arterial embolization of neovessels is a feasible, effective, and safe treatment for patients with symptomatic radiographic knee OA, resulting in significant improvement of pain symptoms in a period of 4 months follow-up compared to sham embolization.
Secondary objectives are
- to assess whether reduction of neovessels is related to pain relief,
- to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief,
- to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and
- to assess whether transcatheter arterial embolization improve the outcome at 1, 4, 8 and 12 months compared to placebo of the: ICOAP, painDETECT, EQ-5D-5L questionnaires and NRS for pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Embolization, Sham embolization
- Keywords
- ranscatheter, embolization, osteoarthritis, arterial
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
transcatheter arterial embolization of neovessels around the knee
Sham embolizationProcedure or surgery
Sham transcatheter arterial embolization of neovessels in the knee
| Study group | Role | What they receive |
|---|---|---|
| Embolization group | Experimental | Group undergoes transcatheter arterial embolization of neovessels around the knee. Receives: Procedure: Embolization |
| Sham Embolization Group | Sham comparator | Group undergoes sham embolization Receives: Procedure: Sham embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS pain sub score
KOOS pain sub score after 4 months
Measured: 4 months
Secondary outcomes (7)
Total KOOS
Total KOOS result
Measured: 1,4,8,12 month(s)
painDETECT questionnaire
painDETECT questionnaire results
Measured: 1,4,8,12 month(s)
ICOAP questionnaire
ICOAP questionnaire results
Measured: 1,4,8,12 month(s)
Pain Score 0-10 Numerical Rating Scale (NRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 1,4,8,12 month(s)
EQ-5D-5L questionnaire
EQ-5D-5L questionnaire results
Measured: 1,4,8,12 month(s)
Pressure pain threshold testing
Pressure pain threshold testing results
Measured: 1,4,8,12 month(s)
Knee MRI
Knee MRI scan results
Measured: 1 and 4 month(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start5 Jun 2019
- Primary completion5 May 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Model description
- Double-blinded randomized placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- William Cook Europe, Stichting Coolsingel
- Responsible party
- Principal investigator, Dr. Edwin Oei, Erasmus Medical Center
- Investigators
- Edwin Edwin, MD, PhD, Principal investigator, Erasmus Medical CenterAdriaan Moelker, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884049
- Sponsor's protocol ID
- METC 2018-081
- Other IDs
- 2018-081
- Acronym
- NEO
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2019
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are willing the share all our available unidentified data on reasonable request
Publications
van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.
PubMed 39353688van Zadelhoff TA, Moelker A, Bierma-Zeinstra SMA, Bos PK, Krestin GP, Oei EHG. Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial. Trials. 2022 Jan 8;23(1):24. doi: 10.1186/s13063-021-05942-x.
PubMed 34998425
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03884049
- Acronym / sponsor ID
- NEO / METC 2018-081
- Conditions
- Osteoarthritis, Knee
- Keywords
- ranscatheter, embolization, osteoarthritis, arterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- William Cook Europe, Stichting Coolsingel
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Mar 2019 (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.
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.
Detailed description
Rationale:
Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.
A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction
Objective:
The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.
The investigators hypothesize that novel transcatheter arterial embolization of neovessels is a feasible, effective, and safe treatment for patients with symptomatic radiographic knee OA, resulting in significant improvement of pain symptoms in a period of 4 months follow-up compared to sham embolization.
Secondary objectives are
- to assess whether reduction of neovessels is related to pain relief,
- to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief,
- to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and
- to assess whether transcatheter arterial embolization improve the outcome at 1, 4, 8 and 12 months compared to placebo of the: ICOAP, painDETECT, EQ-5D-5L questionnaires and NRS for pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded randomized placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Embolization group | Experimental | Procedure: EmbolizationGroup undergoes transcatheter arterial embolization of neovessels around the knee. |
| Sham Embolization Group | Sham comparator | Procedure: Sham embolizationGroup undergoes sham embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age.≥18 years
- Knee pain for a duration of ≥ 6 months
- Knee pain (numeric rating scale ≥4 - ≤8) on at least half of the days in the preceding month at time of inclusion.
- There is insufficient response of conservative treatment for at least 6 months
- Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Embolizationtranscatheter arterial embolization of neovessels around the knee | Procedure or surgery | Embolization group |
| Sham embolizationSham transcatheter arterial embolization of neovessels in the knee | Procedure or surgery | Sham Embolization Group |
Primary outcome
KOOS pain sub score
Time frame: 4 months
KOOS pain sub score after 4 months
7 secondary outcomes
Total KOOS
Time frame: 1,4,8,12 month(s)
painDETECT questionnaire
Time frame: 1,4,8,12 month(s)
ICOAP questionnaire
Time frame: 1,4,8,12 month(s)
Pain Score 0-10 Numerical Rating Scale (NRS)
Time frame: 1,4,8,12 month(s)
EQ-5D-5L questionnaire
Time frame: 1,4,8,12 month(s)
Pressure pain threshold testing
Time frame: 1,4,8,12 month(s)
Knee MRI
Time frame: 1 and 4 month(s)
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 1 Apr 2024.
- Derived from this study: PubMed 39353688van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.
- Derived from this study: PubMed 34998425van Zadelhoff TA, Moelker A, Bierma-Zeinstra SMA, Bos PK, Krestin GP, Oei EHG. Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial. Trials. 2022 Jan 8;23(1):24. doi: 10.1186/s13063-021-05942-x.
- Individual participant dataSharing planned: Yes. We are willing the share all our available unidentified data on reasonable request
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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.
Edwin Edwin, MD, PhD principal investigator
Erasmus Medical Center
Adriaan Moelker, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization in people with Osteoarthritis, Knee, run by Erasmus Medical Center at 1 site in Netherlands.
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 19 inclusion and 0 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 1 Apr 2024. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
KOOS pain sub score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884049, which also lists 2 linked publications.
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 1 Apr 2024.