- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03714659
Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears
September 12, 2019 updated by: Gerard Malanga, New Jersey Regenerative Institute, LLC
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numerical Pain Scale
Time Frame: Baseline and 12 months.
|
Average knee pain between 0 (no pain) and 10 (maximum pain).
|
Baseline and 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee Injury and Osteoarthritis Outcome Score
Time Frame: 12 months.
|
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.
|
12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
March 1, 2018
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
October 17, 2018
First Submitted That Met QC Criteria
October 18, 2018
First Posted (ACTUAL)
October 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 12, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-MN-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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