Optimization of Synvisc-One for Knee OA

NCT02029703 | Terminated Results

• 1 other identifier: CC-GENZYME-2012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Knee Pain; Synvisc-One

Outcome Measures

Primary Outcomes (1)

• Difference in Pain Score Between Groups

  The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection. The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.

  12 and 24 weeks

Study Arms (2)

Sham injection

SHAM COMPARATOR

Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.

Other: Sham Injection

Synvisc-One Injection

ACTIVE COMPARATOR

Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.

Device: Synvisc-One Injection

Interventions

Synvisc-One Injection DEVICE

Synvisc-One Injection

Sham Injection OTHER

Sham injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects meeting the American College of Rheumatology (ACR) criteria for primary knee OA who are age 21 or greater with radiographic and symptomatic evidence of tibio-femoral OA for more than 6 months (unilateral, single joint, Kellgren-Lawrence Grading Scale Score of 2 or 3, medial or lateral +/- patellofemoral).
• Subjects with persistent target knee OA pain despite treatment ≥ 3 months with acetaminophen 4 grams or less or other OA pain treatments.
• Subjects willing to discontinue all prohibited treatments and medications (e.g. opioids, narcotic analgesics, Tramadol) throughout the study period.
• Subjects currently on prescription strength NSAIDs (Non steroidal antiinflammatory drugs) must maintain a stable regimen (no dose increase and no new analgesics) during the entire study period.
• Female subjects of child bearing potential must have a negative serum or urine pregnancy test prior to Synvisc-One® or sham injection.
• Female subjects of child bearing potential must agree to use a medically acceptable form of contraception for at least 1 month prior to Synvisc-One® or sham injection and must agree to continue the use of an acceptable form of contraception for the duration of the study. Otherwise, females must be surgically sterile, or postmenopausal as documented in medical history for at least 1 year.
• Subjects willing and able to commit to a standard 10 week course of physical therapy.
• Subjects willing and able to sign written informed consent.

You may not qualify if:

• Kellgren-Lawrence Grading Scale score of Grade 1 or Grade 4 given the low efficacy of viscosupplements in this population and the KOOS is not validated in this patient population.
• Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry.
• History of viscosupplementation in the target knee joint within 3 months of the baseline visit.
• Isolated patellofemoral OA or isolated anterior knee pain (patellofemoral OA coexisting with tibiofemoral knee OA may be included).
• Symptomatic bilateral knee OA (unless the contralateral knee involvement is limited to radiographic OA and not symptomatic).
• Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
• Clinically apparent knee joint infection, tense effusion or other acute inflammation of the target knee at baseline.
• History of septic OA of any joint; and / or Inflammatory arthropathy such as RA (Rheumatoid Arthritis), gout, pseudogout, lupus, crystalline inflammatory arthropathy, chondrocalcinosis etc.
• Active infection of a lower extremity (e.g. cellulitis).
• Prosthetic implant in either knee.
• Subjects with any clinical indication for arthroscopic surgery.
• Subjects with a planned or scheduled surgery during the course of the study (scheduled or awaiting for arthroscopy or a knee replacement procedure for OA of the knee).
• Subjects with plans to initiate or cease other OA treatments including, but not limited to non- pharmacologic, pharmacologic, surgical, chiropractic, or acupuncture during the course of the study.
• Subjects with plans to initiate, cease or continue any other intra-articular knee joint injection during the course of the study.
• History of systemic and/or intra-articular steroid injection in target knee within one month prior to the baseline visit.

Sponsors & Collaborators

• Elaine Husni: lead

Study Sites (1)

Cleveland Clinic, Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

* Ability to receive HA injections without physical therapy. * FDA approval of Gel-One, the sole one-time injection on the market at the beginning of the study * AAOS Guidelines not supporting the use of HA's for knee OA

Results Point of Contact

• Title: M. Elaine Husni, MD, MPH
• Organization: Cleveland Clinic

HUSNIE@CCF.ORG

216-445-1853

Study Officials

• Elaine Husni, MD MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: August 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Locations

US (1)