Clinical trial NCT03379168: Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis.
Official title: Evaluating the Efficacy of Micro-fragmented Adipose Tissue and Intra-articular Corticosteroid Injections for Symptomatic Knee Osteoarthritis: a Randomized, Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
mesenchymal stem cell
adipose tissue
injection
nonoperative treatment
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be conducted as a randomized, placebo-controlled clinical trial. Patients will be randomized to receive either Lipogems, intra-articular corticosteroids, or a placebo injection of saline. Lipogems is cleared for use by the FDA in orthopaedics and arthroscopy and is offered as a treatment option for knee osteoarthritis. This study will be evaluating the effectiveness (not safety) of Lipogems when compared to corticosteroids and placebo. Thus, no information will be submitted to the FDA.
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Current treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who receive mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are limited by complex regulatory issues. This interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. There have been case reports published showing favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients.

The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint compared to placebo.

Detailed description: Objectives:

1. The purpose of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. Based on limitations of prior research, intra-articular corticosteroids are included as a study group to be evaluated for impact on pain relief and joint functionality in comparison to placebo.
2. The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint.

Background:

Osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Pathologic findings of OA include decreased articular cartilage, joint space narrowing, osteophytes, subchondral sclerosis and bone cysts. Currently, treatment options are confined to symptom management only. Options for treatment include: topical preparations, nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and, in severe cases, total knee arthroplasty. Review of recent recommendations shows limitations to all available treatments. Oral NSAIDs have shown relief, but is limited to patients without risk factors or contraindications. Topical NSAIDs are recommended in elderly patients or those with GI risk factors, rather than oral NSAIDs. However, pain improvement took 12 weeks and was not long-lived, potentially due to compliance issues in application. A recent systematic review of intra-articular corticosteroids reported that, due to low-quality evidence, it is inconclusive whether intra-articular corticosteroids provided any short or long-term pain relief. Taylor's review of hyaluronic acid treatment is hampered by the variability of preparations currently on the market and shortage of double-blind placebo controlled studies, but conflicting data is reported. Osteoarthritis Research Society International currently recommends corticosteroid injections for short-term pain relief only, and is inconclusive in recommending hyaluronic acid.

The aforementioned treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. It is well known that articular cartilage is avascular and lacks innervation, which limits its intrinsic healing and repair capabilities. Chondrocytes, derived from MSCs, have limited potential to replicate, which also limits the intrinsic healing and repair capabilities of articular cartilage. The stromal vascular fraction, containing adipose derived mesenchymal stem cells (MSCs), has historically been isolated successfully via enzymatic processes. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who received MSCs as part of treatment. However, approaches to isolate MSCs are costly, time consuming, require extensive lab equipment, and are currently limited by complex regulatory issues.

Thus, interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection.

As new technologies are becoming available for the treatment of OA, it is important that investigators gather high-quality data on their efficacy and outcomes. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. Although Lipogems is relatively new to the United States, it has been used for a variety of orthopaedic arthroscopic applications overseas including the treatment of knee OA and is being used more frequently now in the United States. As of now, there are no published studies reporting the outcomes of patients who receive Lipogems for knee OA. There have been case reports published showing favorable outcomes. Thus, this would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients. It would also be the only study to date comparing Lipogems to intra-articular corticosteroids and placebo injections. The investigators feel this study design will provide new insight into the efficacy of Lipogems for pain relief of symptomatic knee OA as well as offer new data on the efficacy of intra-articular corticosteroids in this application.

Eligibility criteria: Inclusion Criteria:

* Age of eighteen or older
* Diagnosis of symptomatic knee osteoarthritis
* Radiographic evidence of knee osteoarthritis. Note: For the purposes of this study, radiographic evidence of knee osteoarthritis is defined as any one or more of the following: osteophytes, joint space narrowing, loss of articular cartilage thickness, subchondral sclerosis or cysts.

Exclusion Criteria:

* History of treatment with any intra-articular knee injection
* Current ligament instability as demonstrated by a positive Lachman Test, Anterior or Posterior Drawer Test, or positive Valgus or Varus Stress Test.
* Known allergy to lidocaine
* Under 18 years of age
* Pregnant women
* Prisoners

Primary outcomes:
measure: Change in Visual Analog Pain Scale (VAS) Over Time
timeFrame: Prior to procedure then post-procedure at 2 weeks
Secondary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Over Time
timeFrame: Prior to procedure then post-procedure at 2 weeks
measure: Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
timeFrame: Prior to procedure then post-procedure at 2 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM Hospital
state: New Mexico
Study officials:
affiliation: UNM Health Sciences Center, Dept of Orthopaedic Surgery
name: Dustin Richter, MD
role: PRINCIPAL_INVESTIGATOR
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