Phase 2
N=20
Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears
Tibial Meniscus Injuries · Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03714659 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Numerical Pain Scale — -3.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipogems (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- New Jersey Regenerative Institute, LLC
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numerical Pain Scale |
-3.2 | — |
| SECONDARY Change in Knee Injury and Osteoarthritis Outcome Score |
17.5; 17.3; 20.5; 26.3; 28.4 | — |
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. 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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03714659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.