Synvisc-One for Younger, Active Patients With Osteoarthritis

NCT01625013 | Completed Results

• 1 other identifier: UCSF-SYNVISC-ONE 001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to study use of viscosupplementation as a treatment of pain for young individuals who are active. Typically viscosupplementation is considered an intervention for knee osteoarthritis often for older patients who are less active. Many young active patients can also develop knee osteoarthritis after trauma or surgery or for congenital reasons. Treatment of these patients commonly are steroid injections which have more biologically detrimental effects for cartilage compared to viscosupplementation Synvisc One injections which are a single injection will be used to determine effectiveness of reducing pain and maintaining an active healthy lifestyle for younger patients aged 30-50 years old.

Conditions

Osteoarthritis

Keywords

osteoarthritis; viscosupplementation; Active; Knee; Synvisc-One

Outcome Measures

Primary Outcomes (1)

• "Worst Knee Pain" Likert Scale (0-10) Reported on Survey

  Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well. Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.

  26 weeks after injection at baseline

Secondary Outcomes (3)

• Patient Acceptable Symptom Score (The Effect of Repeated Treatments)

  26 weeks post-injection Number 2, an average of 52 weeks

• Minimal Clinical Important Improvement (The Effect of Repeated Injections)

  up to 15 months (within 3 months from the second Synvisc One injection)

• Identify the Effects of Treatment on Activity Levels

  26 weeks post-injection at baseline through 3 years post-injection

Study Arms (1)

Synvisc-One

EXPERIMENTAL

Device: Synvisc-One (G-F 20)

Interventions

Synvisc-One (G-F 20) DEVICE

Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.

Synvisc-One

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients aged 30-50 years
• History of symptomatic unilateral primary or secondary knee OA for more than 6 months
• Signed written informed consent
• Radiographic evidence of Kellgren-Lawrence Grade I or II OA of the target knee
• Body Mass Index (BMI) \< 30 kg/m2
• Activity criteria (Tegner score \> 3)
• Continued target knee OA pain despite conservative treatment ≥ 3 months (e.g., weight reduction, physical therapy, analgesics)
• Willing to withhold intake of NSAIDs (including COX-2 inhibitors) and analgesics, for a washout period of minimum 3 days up to 21 days prior to baseline visit (depending on medication)
• Willing to discontinue prohibited treatments and medications throughout study period
• Completed OA medication washout period
• Target knee pain 4-8 (0-10 NRS) during most painful knee movement (Worst Knee Pain)
• If female, must have had a negative urine pregnancy test and used a medically acceptable form of contraception for at least 1 month prior to baseline and agree to continued use 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. The fetal safety profile for G-F 20 is unknown. Pregnancy will affect the individual's regular activity levels. Females who become pregnant during the study will be excluded from the study. Subjects who become pregnant will be followed up by telephone every 3 months to check for any adverse effects. They will also be recommended to follow routine obstetric visits. Males should be able to father children as it has no expected effects on activity levels.

You may not qualify if:

• Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry
• Clinically apparent tense effusion or other acute inflammation of the target knee at baseline
• History of target knee viscosupplementation treatment
• History of major surgery for OA in target knee including arthroplasty or tibial osteotomy
• Arthroscopic surgery or intraarticular steroid injection in target knee within six months of baseline visit
• Significant (as judged by the Investigator) alignment deformity of target knee
• Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle
• History of:
• Septic OA of any joint
• Inflammatory arthropathy such as RA, gout, pseudogout, lupus, crystalline inflammatory arthropathy
• Active infection of lower extremity
• Known significant acute and/or concurrent medical disease including, but not limited to current malignancy, history of transplant surgery, congestive heart failure, significant unstable cardiovascular disease, renal hepatic pulmonary, endocrine, metabolic, or GI condition
• Any known contraindication to acetaminophen
• Venous or lymphatic stasis in either leg
• Peripheral vascular disease

Sponsors & Collaborators

• Anthony Luke: lead

Study Sites (1)

University of California

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Results Point of Contact

• Title: Anthony Luke, MD
• Organization: University of California, San Francisco

Anthony.Luke@ucsf.edu

4155146120

Study Officials

• Anthony Luke, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Orthopaedic Surgery

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 21, 2012
• Study Start: November 1, 2011
• Primary Completion: October 2, 2017
• Study Completion: August 7, 2019
• Last Updated: May 7, 2021
• Results First Posted: March 27, 2020

Record last verified: 2021-04

Locations

US (1)