Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity

NCT01810848 | Terminated Phase 1

• 1 other identifier: CORT
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts. It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals. Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Osteoarthritis; Synvisc; Hylan G-F 20; Exercise; Cardiovascular risk; Knee pain; Pain

Outcome Measures

Primary Outcomes (1)

• MET Level (Exercise capacity)

  6 Months

Secondary Outcomes (1)

• KOOS (Knee Injury and Osteoarthritis Outcome Score)

  6 Months

Study Arms (2)

Hylan G-F 20

ACTIVE COMPARATOR

Patients will receive a single injection of hylan G-F 20 6ml into affected knee. Injections will be performed under fluoroscopic guidance.

Device: Hylan G-F 20

Control

SHAM COMPARATOR

Patients will receive a single sham puncture into the affected knee. Sham punctures will be identical to the treatment injections in all other respects, including duration, use of sterile drapes, sterile preparation, and dimming of the lights. This procedure will include a 22g needle stick through the skin without violating the joint capsule or performing arthrocentesis.

Other: Control

Interventions

Hylan G-F 20 DEVICE

Synvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint ("intra-articular") for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Also known as: Synvisc, Sodium hyaluronate

Hylan G-F 20

Control OTHER

Control is puncture of the skin at the site of the knee.

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female individuals aged between 40 and 70 meeting the American College of Rheumatology (ACR) criteria for primary knee OA with radiographic and symptomatic evidence of TF OA for ≥6 months.
• Radiographic osteoarthritis Kellgren-Lawrence Grade II-III (radiographs taken at entry) in affected knee.
• Average pain numeric rating (defined as moderate level) of 4 - 8 on a scale of zero to 10 over the past week.
• No previous viscosupplement therapy in any joint in past 12 months at the time of randomization.
• No intra-articular steroids in the past 6 months.
• Currently sedentary per American College of Sports Medicine (ACSM) criteria (MET level \<9) and at least one of the following cardiovascular risk factors:
• Obesity (BMI between 30 and 40)
• Diabetes mellitus
• HTN (JNC guidelines for HTN stage 1: Systolic \>/=140 and diastolic \>/= 90)
• Dyslipidemia (ATP3 Guidelines for dyslipidemia: LDL\>160, total cholesterol \>/=240 and HDL\<40)
• Established CAD per clinical or imaging diagnosis
• Allowed medications include stable prescription dose of NSAIDS and/or tramadol. Ad lib use of OTC analgesics will be allowed in both groups.

You may not qualify if:

• Grade I and IV OA.
• History of viscosupplementation in any joint in the past 12 months at the time of baseline visit.
• Isolated patello-femoral OA or isolated anterior knee pain (patello-femoral OA co-existing with tibia femoral KOA may be included).
• Symptomatic bilateral knee OA (unless the contra-lateral knee involvement is limited to radiographic OA and not symptomatic).
• Ipsi-lateral symptomatic OA of hip or ankle; contra-lateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
• Clinically apparent tense effusion or other acute inflammation of the target knee at baseline.
• History of:
• Septic OA of any joint
• Inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnosis in judgment of the investigator.
• Active infection of lower extremity (e.g., cellulitis).
• Prosthetic implant in hip and/or lower extremities.
• Any clinical indication for arthroscopic surgery at the time of enrollment.
• Planned surgeries during the trial period (e.g., scheduled/awaiting for arthroscopy or a knee replacement procedure for OA of the knee).
• Plans to initiate other OA treatments including, but not limited to non-pharmacologic, pharmacologic, surgical, chiropractic, acupuncture, yoga, Tai chi, physical therapy during the study period
• Any other intra-articular knee joint injection during the study.

Sponsors & Collaborators

• OhioHealth: lead
• Sanofi: collaborator

Study Sites (1)

McConnell Heart Health Center

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph J Ruane, DO

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 29, 2016

Record last verified: 2015-03

Locations

US (1)