Serum and Synovium Protease Inhibitor Levels in Primary and Secondary Osteoarthritic Joints
Paused
Conditions studied: Osteoarthritis of the Knee
In brief
Osteoarthritis (OA) is the irreversible degeneration of articular cartilage and underlying bone. It poses a major healthcare problem as it is the leading cause of joint disease and disability in the United States. It was traditionally thought that OA was a consequence of aging and joint trauma. However, it is now thought that OA is a result of the interplay of multiple genetic, biomechanical, and biochemical factors that disrupt the normal homeostasis of cartilage, bone, and synovium. OA is classified into two groups, primary and secondary. Primary OA is classically polyarticular and peripheral while secondary OA can commonly be attributed to a specific cause, limited to a singular joint, and a result of trauma. It is known as post-traumatic OA (PTOA). Other causes of secondary OA include congenital disorders, calcium pyrophosphate dehydrate deposition disease, and other diseases. Regardless of classification, genetic variation in the normal metabolism of cartilage and bone is thought to play a role in the progression of OA. Furthermore, the polyarticular presentation of primary idiopathic osteoarthritis suggests that it may have a stronger genetic component as compared to secondary OA, indicating a deviation from normal cartilage and bone homeostasis. Matrix metalloproteinases (MMP) and their inhibitors take part in the metabolism of cartilage and bone. MMPs are enzymes that catalyze the degradation of elements within joint spaces while their inhibitors cease this activity. Alpha-2-Macroglobulin (A2M) is a naturally-occurring plasma glycoprotein that functions throughout multiple tissues and extracellular spaces as a protease inhibitor but does not normally reach high levels within the intra-articular joint space. A2M is believed to modulate the systemic inflammatory response by its ability to bait, trap, and clear various MMPs and cytokines. Concentrated A2M directly addresses the roles of cytokines and catabolic enzymes known to participate in the development of osteoarthritis. Cytonics has shown that A2M can inhibit cartilage degradation in vitro. As the role of MMPs and protease inhibitors have emerged as key components of OA, the investigation of regulators of MMP has become of interest to elucidate the pathogenesis and possible novel treatments of OA. This study aims to measure and correlate the levels of alpha-2-Macroglobulin (A2M) in plasma and knee joint OA between primary post-traumatic (PTOA) and secondary osteoarthritis groups.
Key facts
- Study ID
- NCT01613833
- Run by
- Scuderi, Gaetano J., M.D.
- People needed
- 40
- Starts
- 2012-03-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2017-10-09
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Group 1, Non-traumatic primary OA:
- Subject scheduled to undergo primary unilateral total knee arthroplasty for primary osteoarthritis as determined by an orthopedic surgeon
- Subject is male or female over 45-75 years of age
- Subject is able to read and understand informed consent form and must subsequently sign and date consent form
- Group 2, Secondary post-traumatic/overuse OA:
- Subject scheduled to undergo unilateral total knee arthroplasty secondary osteoarthritis as determined by an orthopedic surgeon, which MUST include either previous injury or surgery to the operative knee.
- Subject is male or female 45-75 years of age
- Subject is able to read and understand informed consent form and must subsequently sign and date consent form
You may not qualify if…
- Group 1, Non-traumatic primary OA:
- History of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis)
- Indication for surgery other than osteoarthritis
- Revision total knee arthroplasty
- Age >75, age <44
- Unable to read, understand, or sign informed consent form
- Previous knee infection
- Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition disease
- Group 2, Secondary post-traumatic/overuse OA:
- History of inflammatory arthritis (e.g. rheumatoid arthritis, ankyolosing spondylitis)
- Indication for surgery other than osteoarthritis
- Age >75, age <44
- Unable to read, understand, or sign informed consent form
- Previous knee infection
- Congenital disorders of the knee, calcium pyrophosphate dehydrate deposition disease
Where it is running
- Stanford University Hospital — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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