Tibial Meniscus InjuriesPhase 2NCT03714659
Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears
A Phase 2 study testing Lipogems in people with Tibial Meniscus Injuries and Osteoarthritis, Knee, run by New Jersey Regenerative Institute, LLC.
Trial summary
The menisci of the knee are essential fibro-cartilaginous structures that contribute in static weight bearing, distributing compressive forces during joint movement, joint lubrication, joint stabilization, and proprioception. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Tibial Meniscus Injuries, Osteoarthritis, Knee
- What is being tested?
- Lipogems
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 and older
- Symptoms consistent with torn meniscus (at least one of clicking popping, giving way, pain with pivot or torque, pain that is episodic)
- Pain that can be provoked by palpitation or compression of the joint line.
- Pain located in the medial joint line that has persisted for at least 3 months.
- MRI or arthroscopic evidence of meniscal tear.
- Failed conservative treatment which has included: anti-inflammatory or other medications for pain; physical therapy; injections including corticosteroid injections and/or hyaluronic acid injections.
- This would include patients who have been told by an orthopedic surgeon that they would be a candidate for arthroscopic partial meniscectomy.
Who cannot join
- Chronically locked knee.
- Prior surgery performed on effected knee
- Assessment showing anything other than degenerative tears of the medial meniscus requiring surgical intervention.
- Recent (within 6 weeks) treatment with PRP, cortisone oral or by injection, or Hyaluronic injection.
- Any disease or condition the investigator feels would hinder treatment.
- Any contra-indication to lipoaspirate which includes: bleeding disorder, infection, pregnancy; allergy to anesthetic agents.
- Malignancy within the last 5 years.
About this study
Official title: Clinical Evaluation of Autologous Micro-fragmented Adipose Tissue as a Treatment Option for Meniscus Tears
The menisci of the knee are essential fibro-cartilaginous structures that contribute in static weight bearing, distributing compressive forces during joint movement, joint lubrication, joint stabilization, and proprioception. The menisci are commonly torn, interfering with these vital functions, with an estimated mean annual incidence as high as 60-70 per 100,000 knee injuries. When torn, the odds of developing future osteoarthritis within 2 years of follow-up can be as high as 5.92. The management of meniscal tears remains a challenge given the poor intrinsic healing capacity of tears occurring in the inner, avascular, portion of the meniscus where direct surgical repair techniques are commonly unsuccessful. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes).The aim of this study is to explore the potential of Lipogems® micro-fragmented adipose tissue as a meaningful treatment option for meniscus tears. Patients treated with MFAT with intra-meniscal injections under continuous ultrasound guidance are expected to report clinically meaningful improvements in knee pain and knee function after one year. Knee pain and function will be measured using a numerical pain scale (NPS) and the Knee Injury and Osteoarthritis Outcome Scale (KOOS).
Read the detailed description
This is a prospective pilot study to evaluate the safety and efficacy of autologous, micro fragmented adipose tissue (Lipogems®) injection under continuous ultrasound guidance for knee pain secondary to meniscal tear(s). 20 subjects will be enrolled who present for evaluation and treatment of knee pain with associated meniscal tear despite prior conservative management. Failure of conservative management was defined as persistent pain despite the use of anti-inflammatory or other medications for pain, physical therapy, corticosteroid injections, or hyaluronic acid injections. This also included patients who were told that they were a candidate for arthroscopic surgery by an orthopedic surgeon due to failure of conservative measures. Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. 1-2 mLs of micro-fragmented adipose tissue will be injected directly into visualized meniscal tears using continues ultrasound guidance. The remaining injectate will be administer into the knee joint by lateral suprapatellar approach. Post-injection guidelines including weight bearing restrictions--non-weightbearing with crutches for one week, then weight bearing as tolerated for simple daily activities--refraining from running and jumping activities and refraining from repetitive flexion beyond 90 degrees for 4 weeks total. If there was no significant pain, swelling, joint-line tenderness, and near full range of motion, unrestricted activities were allowed at the 6-8-week time-frame. Complications of both the harvest and injection sites were recorded via questionnaire at 1 and 4-week follow-up. Subjects were seen for initial follow-up at 4 weeks. They then completed surveys at 3, 6, and 12 months, including the Knee Injury and Osteoarthritis Outcome Scale (KOOS) subscales and the numerical pain scale (NPS). The NPS is one of the most common measures of pain intensity and is used frequently in both research and clinical practice. The scale is a well validated and reliable for determining change in pain over time. Pain is rated on an 11-point scale, 0-10, with 0 representing "no pain" and 10 representing "worst imaginable pain". It is well suited to this study given ease of administration in person or in online survey format. The minimum clinically important difference (MCID) for patients with knee pain secondary to osteoarthritis has been established as 2. The KOOS is also widely used in research and clinical practice, including in large-scale databases and registries. It is intended to be used in the setting of knee pain or injury that can result in post-traumatic osteoarthritis including meniscus tears. It can be used over short and long-term intervals and to asses change over time. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The re-test reliability has also been well established in patients with knee injuries and the MCID has been established as 8-10.
- Conditions
- Tibial Meniscus Injuries, Osteoarthritis, Knee
- Being tested
- Lipogems
- Medical subject headings
- Tibial Meniscus Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipogemsDevice
Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires. Receives: Device: Lipogems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Pain Scale
Average knee pain between 0 (no pain) and 10 (maximum pain).
Measured: Baseline and 12 months.
Secondary outcomes (1)
Change in Knee Injury and Osteoarthritis Outcome Score
A scale with five subdomains that aim to capture pain, symptoms, functional limitations, and effects on quality of life caused by (in this study) meniscal injury. Each subdomain is measured from 0 (complete impairment) to 100 (no impairment). A higher score indicates less pain or better function.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Jan 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial Meniscus InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Jersey Regenerative Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gerard Malanga, New Jersey Regenerative Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714659
- Sponsor's protocol ID
- LG-MN-201
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2018
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Malanga GA, Chirichella PS, Hogaboom NS, Capella T. Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study. Int Orthop. 2021 Feb;45(2):473-480. doi: 10.1007/s00264-020-04835-z. Epub 2020 Oct 7.
PubMed 33026537
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Autologous Micro-fragmented Adipose Tissue as a Treatment Option for Meniscus Tears
- ClinicalTrials.gov ID
- NCT03714659
- Acronym / sponsor ID
- LG-MN-201
- Conditions
- Tibial Meniscus Injuries, Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New Jersey Regenerative Institute, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The menisci of the knee are essential fibro-cartilaginous structures that contribute in static weight bearing, distributing compressive forces during joint movement, joint lubrication, joint stabilization, and proprioception. The menisci are commonly torn, interfering with these vital functions, with an estimated mean annual incidence as high as 60-70 per 100,000 knee injuries. When torn, the odds of developing future osteoarthritis within 2 years of follow-up can be as high as 5.92. The management of meniscal tears remains a challenge given the poor intrinsic healing capacity of tears occurring in the inner, avascular, portion of the meniscus where direct surgical repair techniques are commonly unsuccessful. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes).The aim of this study is to explore the potential of Lipogems® micro-fragmented adipose tissue as a meaningful treatment option for meniscus tears. Patients treated with MFAT with intra-meniscal injections under continuous ultrasound guidance are expected to report clinically meaningful improvements in knee pain and knee function after one year. Knee pain and function will be measured using a numerical pain scale (NPS) and the Knee Injury and Osteoarthritis Outcome Scale (KOOS).
Detailed description
This is a prospective pilot study to evaluate the safety and efficacy of autologous, micro fragmented adipose tissue (Lipogems®) injection under continuous ultrasound guidance for knee pain secondary to meniscal tear(s). 20 subjects will be enrolled who present for evaluation and treatment of knee pain with associated meniscal tear despite prior conservative management. Failure of conservative management was defined as persistent pain despite the use of anti-inflammatory or other medications for pain, physical therapy, corticosteroid injections, or hyaluronic acid injections. This also included patients who were told that they were a candidate for arthroscopic surgery by an orthopedic surgeon due to failure of conservative measures. Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. 1-2 mLs of micro-fragmented adipose tissue will be injected directly into visualized meniscal tears using continues ultrasound guidance. The remaining injectate will be administer into the knee joint by lateral suprapatellar approach. Post-injection guidelines including weight bearing restrictions--non-weightbearing with crutches for one week, then weight bearing as tolerated for simple daily activities--refraining from running and jumping activities and refraining from repetitive flexion beyond 90 degrees for 4 weeks total. If there was no significant pain, swelling, joint-line tenderness, and near full range of motion, unrestricted activities were allowed at the 6-8-week time-frame. Complications of both the harvest and injection sites were recorded via questionnaire at 1 and 4-week follow-up. Subjects were seen for initial follow-up at 4 weeks. They then completed surveys at 3, 6, and 12 months, including the Knee Injury and Osteoarthritis Outcome Scale (KOOS) subscales and the numerical pain scale (NPS). The NPS is one of the most common measures of pain intensity and is used frequently in both research and clinical practice. The scale is a well validated and reliable for determining change in pain over time. Pain is rated on an 11-point scale, 0-10, with 0 representing "no pain" and 10 representing "worst imaginable pain". It is well suited to this study given ease of administration in person or in online survey format. The minimum clinically important difference (MCID) for patients with knee pain secondary to osteoarthritis has been established as 2. The KOOS is also widely used in research and clinical practice, including in large-scale databases and registries. It is intended to be used in the setting of knee pain or injury that can result in post-traumatic osteoarthritis including meniscus tears. It can be used over short and long-term intervals and to asses change over time. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The re-test reliability has also been well established in patients with knee injuries and the MCID has been established as 8-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LipogemsGroup will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 35 and older
- Symptoms consistent with torn meniscus (at least one of clicking popping, giving way, pain with pivot or torque, pain that is episodic)
- Pain that can be provoked by palpitation or compression of the joint line.
- Pain located in the medial joint line that has persisted for at least 3 months.
- MRI or arthroscopic evidence of meniscal tear.
Key exclusion criteria (7 listed)
- Chronically locked knee.
- Prior surgery performed on effected knee
- Assessment showing anything other than degenerative tears of the medial meniscus requiring surgical intervention.
- Recent (within 6 weeks) treatment with PRP, cortisone oral or by injection, or Hyaluronic injection.
- Any disease or condition the investigator feels would hinder treatment.
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 |
|---|---|---|
| LipogemsLipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint. | Device | Intervention |
Primary outcome
Change in Numerical Pain Scale
Time frame: Baseline and 12 months.
Average knee pain between 0 (no pain) and 10 (maximum pain).
1 secondary outcome
Change in Knee Injury and Osteoarthritis Outcome Score
Time frame: 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33026537Malanga GA, Chirichella PS, Hogaboom NS, Capella T. Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study. Int Orthop. 2021 Feb;45(2):473-480. doi: 10.1007/s00264-020-04835-z. Epub 2020 Oct 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipogems in people with Tibial Meniscus Injuries and Osteoarthritis, Knee, run by New Jersey Regenerative Institute, LLC.
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 7 inclusion and 7 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 25 Sep 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Numerical Pain Scale (time frame: Baseline and 12 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 NCT03714659, which also lists 1 linked publication.
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 25 Sep 2019.