Post-Meniscectomy Pain SyndromeEARTHNCT06705985
Early Artificial Lateral Prosthesis
A study testing Implantation of lateral meniscus prosthesis in people with Post-Meniscectomy Pain Syndrome, run by ATRO Medical B.V. at 1 site in Netherlands.
Trial summary
The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Meniscectomy Pain Syndrome
- What is being tested?
- Implantation of lateral meniscus prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2024to 1 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is aged 18 to 70 years (inclusive) at the time of screening
- Has a history of partial or total meniscectomy
- Has post-meniscectomy pain syndrome (defined as symptomatic unicompartmental pain in the meniscus- deficient knee without severe cartilage damage- Kellgren \& Lawrence grade 3-4) in the lateral compartment as confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 at the time of screening
- Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, and intra-articular corticosteroids)
- Has neutral alignment < ± 3° of the mechanical axis
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- Is willing to be implanted with the LMP System and to comply with instruction for use
- Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI
- Is able and willing to understand and sign the study Informed Consent Form
- Is able to read and understand the national language of the country in which the clinical site is located
Who cannot join
- Has progressed knee osteoarthritis, Kellgren \& Lawrence grade 3- 4 in the lateral compartment
- Has evidence of a modified Outerbridge Grade IV cartilage loss on the lateral tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis
- Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment
- Has a varus or valgus knee deformity of > 3°
- Has a valgus alignment that is not passively correctable
- Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
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- Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
- Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment
- Had an ACL reconstruction performed < 9 months prior to surgery
- Has a BMI > 35 at the time of screening
- Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the lateral meniscus prosthesis
- Has a knee flexion contracture > 10°
- Has flexion < 90°
- Had a knee alignment correction osteotomy < 9 months ago
- Has insufficiency fractures or avascular necrosis of the lateral compartment
- Has an active infection or tumor (local or systemic)
- Has any type of knee joint inflammatory disease including Sjogren's syndrome
- Has neuropathic knee osteoarthropathy, also known as Charcot joint
- Has any medical condition that does not allow possible arthroscopy of the knee
- Has neurological deficit (sensory, motor, or reflex)
- Anticipates having another lower extremity surgery during the study period
- Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
- Has received any corticosteroid knee injections ≤ 3 months prior to surgery
- Has proven osteoporosis
- Is on immunostimulating or immunosuppressing agents
- Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or study outcomes (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
- Is a female who is lactating, expecting, or is intending to become pregnant during the study period
- Is an active smoker at the time of surgery
- Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
- Has a condition or be in a situation that, in the Investigator's opinion, may confound the clinical investigation results, may risk the safety of the patient, or may interfere significantly with the subject's participation in the clinical investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Radboudumc
Nijmegen, Gelderland
Katja Saris, PhD, 003124361492, Katja.Saris-deLeuw@Radboudumc.nl
S van de Groes, MD, PhD
About this study
Official title: Treatment of Lateral Knee Joint Pain with Artificial Lateral Meniscus Prosthesis After Meniscectomy
The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.
- Conditions
- Post-Meniscectomy Pain Syndrome
- Being tested
- Implantation of lateral meniscus prosthesis
- Keywords
- meniscus, lateral, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of lateral meniscus prosthesisDevice
Implantation of a lateral meniscus prosthesis after meniscectomy.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Meniscus Prosthesis | Experimental | Implantation of the Lateral Meniscus Prosthesis, intended to replace the function of the natural meniscus to provide unicompartmental pain relief in the meniscus-deficient knee. Receives: Device: Implantation of lateral meniscus prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events within 12 months after implantation.
Measured: 12 months after implantation.
Implant integrity
Assessed by MRI.
Measured: 12 months after implantation.
Secondary outcomes (13)
KOOS
KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months.
Measured: 24 months.
Lysholm
Lysholm scale at 6 weeks, 3, 6, 12, 24 months.
Measured: 24 months.
OKS
OKS at 6, 12, 24 months.
Measured: 24 months.
EQ-5D-5L
EQ-5D-5L at 6, 12, 24 months.
Measured: 24 months.
WORQ
WORQ at 6 weeks, 3, 6, 12, 24 months.
Measured: 24 months.
SF-36
SF-36 at 6, 12, 24 months.
Measured: 24 months.
Likert - Patient satisfaction
Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months.
Measured: 24 months.
Tegner Activity Scale
Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months.
Measured: 24 months.
IKDC Knee Examination Form
IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months.
Measured: 24 months.
Knee X-ray (weight-bearing)
Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space.
Measured: 24 months.
Knee X-ray (weight-bearing, long-leg)
- Knee X-ray (weight-bearing, long-leg) at 6, 12, and 24 months to evaluate the mechanical axis.
Measured: 24 months.
Knee X-ray (non-weight-bearing, supine)
Knee X-ray (non-weight-bearing, supine) at 12, and 24 months to evaluate the mechanical axis.
Measured: 24 months.
Knee MRI (non-weight-bearing)
Knee MRI (non-weight-bearing) at implantation surgery (+(within
1 week, preferably peroperative), 6, 12, and 24 months for implant and joint integrity (cartilage status) assessment (including focal defects, bone marrow lesions, and bone tunnels/fixation sites).
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 posted26 Nov 2024
- Study start21 Nov 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Meniscectomy Pain SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The objective of the clinical investigation is to evaluate the safety and performance of the LMP system and to demonstrate that the system is able to replace the function of the natural meniscus to provide pain relief in the lateral compartment of the meniscus-deficient knee. No formal hypothesis testing will be conducted, given the feasibility design of this clinical investigation. Evaluation of safety of the LMP system will occur throughout the investigation with the reporting of the nature and frequency of all adverse events observed during the clinical investigation and their timing, severity and relatedness to the investigational device or procedure. In addition, the incidence and nature of secondary surgical intervention will be assessed.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ATRO Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705985
- Sponsor's protocol ID
- AM-101
- Acronym
- EARTH
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lateral Knee Joint Pain with Artificial Lateral Meniscus Prosthesis After Meniscectomy
- ClinicalTrials.gov ID
- NCT06705985
- Acronym / sponsor ID
- EARTH / AM-101
- Conditions
- Post-Meniscectomy Pain Syndrome
- Keywords
- meniscus, lateral, prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ATRO Medical B.V.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 Nov 2024 (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 device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The objective of the clinical investigation is to evaluate the safety and performance of the LMP system and to demonstrate that the system is able to replace the function of the natural meniscus to provide pain relief in the lateral compartment of the meniscus-deficient knee. No formal hypothesis testing will be conducted, given the feasibility design of this clinical investigation. Evaluation of safety of the LMP system will occur throughout the investigation with the reporting of the nature and frequency of all adverse events observed during the clinical investigation and their timing, severity and relatedness to the investigational device or procedure. In addition, the incidence and nature of secondary surgical intervention will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Lateral Meniscus Prosthesis | Experimental | Device: Implantation of lateral meniscus prosthesisImplantation of the Lateral Meniscus Prosthesis, intended to replace the function of the natural meniscus to provide unicompartmental pain relief in the meniscus-deficient knee. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is aged 18 to 70 years (inclusive) at the time of screening
- Has a history of partial or total meniscectomy
- Has post-meniscectomy pain syndrome (defined as symptomatic unicompartmental pain in the meniscus- deficient knee without severe cartilage damage- Kellgren \& Lawrence grade 3-4) in the lateral compartment as confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 at the time of screening
- Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, and intra-articular corticosteroids)
Key exclusion criteria (30 listed)
- Has progressed knee osteoarthritis, Kellgren \& Lawrence grade 3- 4 in the lateral compartment
- Has evidence of a modified Outerbridge Grade IV cartilage loss on the lateral tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis
- Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment
- Has a varus or valgus knee deformity of > 3°
- Has a valgus alignment that is not passively correctable
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 |
|---|---|---|
| Implantation of lateral meniscus prosthesisImplantation of a lateral meniscus prosthesis after meniscectomy. | Device | Lateral Meniscus Prosthesis |
Primary outcome
Adverse events
Time frame: 12 months after implantation.
Adverse events within 12 months after implantation.
Implant integrity
Time frame: 12 months after implantation.
Assessed by MRI.
13 secondary outcomes
KOOS
Time frame: 24 months.
Lysholm
Time frame: 24 months.
OKS
Time frame: 24 months.
EQ-5D-5L
Time frame: 24 months.
WORQ
Time frame: 24 months.
SF-36
Time frame: 24 months.
Likert - Patient satisfaction
Time frame: 24 months.
Tegner Activity Scale
Time frame: 24 months.
IKDC Knee Examination Form
Time frame: 24 months.
Knee X-ray (weight-bearing)
Time frame: 24 months.
Knee X-ray (weight-bearing, long-leg)
Time frame: 24 months.
Knee X-ray (non-weight-bearing, supine)
Time frame: 24 months.
Knee MRI (non-weight-bearing)
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 26 Nov 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of lateral meniscus prosthesis in people with Post-Meniscectomy Pain Syndrome, run by ATRO Medical B.V. 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 10 inclusion and 30 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 26 Nov 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. 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?
Contact CDD (0031616672227, info@atromedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 12 months after implantation.). 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 26 Nov 2024.