Recruitment

Recruitment Status
Terminated
Estimated Enrollment
275

Inclusion Criterias

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 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 sign written informed consent.
...
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 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 sign written informed consent.
Female subjects of child bearing potential must have a negative serum or urine pregnancy test prior to Synvisc-One® or sham injection.
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 willing to discontinue all prohibited treatments and medications (e.g. opioids, narcotic analgesics, Tramadol) throughout the study period.
Subjects with persistent target knee OA pain despite treatment ≥ 3 months with acetaminophen 4 grams or less or other OA pain treatments.
Subjects willing and able to commit to a standard 10 week course of physical therapy.

Exclusion Criterias

Subjects who plan to move or relocate out of area inhibiting their ability to complete the entire physical therapy regimen as defined by the protocol and prescribed by the investigator.
Subjects currently enrolled in any other experimental clinical trial or history of trial enrollment within three months of baseline.
Any known contraindication to acetaminophen.
...
Subjects who plan to move or relocate out of area inhibiting their ability to complete the entire physical therapy regimen as defined by the protocol and prescribed by the investigator.
Subjects currently enrolled in any other experimental clinical trial or history of trial enrollment within three months of baseline.
Any known contraindication to acetaminophen.
Knee pain is associated with a Worker's Compensation Claim.
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.
Clinically apparent knee joint infection, tense effusion or other acute inflammation of the target knee at baseline.
Known psychiatric disorder.
History of viscosupplementation in the target knee joint within 3 months of the baseline visit.
History of systemic and/or intra-articular steroid injection in target knee within one month prior to the baseline visit.
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.
Cruciate / collateral knee ligament instability, ligament laxity, or meniscal instability of target knee.
Body mass index (BMI) > 40.
Active infection of a lower extremity (e.g. cellulitis).
Subjects with any clinical indication for arthroscopic surgery.
Obvious cartilage defects producing mechanical symptoms (i.e. locking).
Currently pregnant or new mothers who are breastfeeding.
Suspected meniscus injury, including a positive McMuray's test or significant joint line tenderness.
History of complete menisectomy.
Past or current history of peripheral vascular disease pertaining to the involved limb.
History of open knee surgery in affected knee or history of arthroscopic surgery in affected knee in past year.
Symptomatic bilateral knee OA (unless the contralateral knee involvement is limited to radiographic OA and not symptomatic).
Significant alignment deformity such as varus / valgus of target knee in the judgment of the investigator.
Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry.
Subjects with plans to initiate, cease or continue any other intra-articular knee joint injection during the course of the study.
Venous or lymphatic stasis in either leg.
Use of prohibited pain medications.
Known significant acute and / or concurrent medical comorbidities including, but not limited to current malignancy, history of transplant surgery, congestive heart failure, significant unstable cardiovascular disease, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, or neurological condition that in the judgment of the investigator would significantly impact life expectancy and / or the conduct of the trial.
Subjects currently prescribed chronic opioid analgesics at time of baseline visit that cannot be discontinued.
Prosthetic implant in either knee.
Concurrent multisystem or multilimb trauma.
Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
History of septic OA of any joint; and / or Inflammatory arthropathy such as RA (Rheumatoid Arthritis), gout, pseudogout, lupus, crystalline inflammatory arthropathy, chondrocalcinosis etc.
Isolated patellofemoral OA or isolated anterior knee pain (patellofemoral OA coexisting with tibiofemoral knee OA may be included).
Patellar tendonitis.
Female subjects interested in conceiving a child during the study period.

Summary

Conditions
Knee Osteoarthritis
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Description

This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study. Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection. T...

This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study. Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection. The post-treatment course of physical therapy will begin between Day 3 and Day 14 and will last up to 12 weeks in duration (PT ends at study Week 12). Subjects are encouraged to complete between 6 and 16 physical therapy visits within 10-12 weeks of physical therapy treatment as determined by the treating Physical Therapist.

Inclusion Criterias

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 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 sign written informed consent.
...
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 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 sign written informed consent.
Female subjects of child bearing potential must have a negative serum or urine pregnancy test prior to Synvisc-One® or sham injection.
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 willing to discontinue all prohibited treatments and medications (e.g. opioids, narcotic analgesics, Tramadol) throughout the study period.
Subjects with persistent target knee OA pain despite treatment ≥ 3 months with acetaminophen 4 grams or less or other OA pain treatments.
Subjects willing and able to commit to a standard 10 week course of physical therapy.

Exclusion Criterias

Subjects who plan to move or relocate out of area inhibiting their ability to complete the entire physical therapy regimen as defined by the protocol and prescribed by the investigator.
Subjects currently enrolled in any other experimental clinical trial or history of trial enrollment within three months of baseline.
Any known contraindication to acetaminophen.
...
Subjects who plan to move or relocate out of area inhibiting their ability to complete the entire physical therapy regimen as defined by the protocol and prescribed by the investigator.
Subjects currently enrolled in any other experimental clinical trial or history of trial enrollment within three months of baseline.
Any known contraindication to acetaminophen.
Knee pain is associated with a Worker's Compensation Claim.
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.
Clinically apparent knee joint infection, tense effusion or other acute inflammation of the target knee at baseline.
Known psychiatric disorder.
History of viscosupplementation in the target knee joint within 3 months of the baseline visit.
History of systemic and/or intra-articular steroid injection in target knee within one month prior to the baseline visit.
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.
Cruciate / collateral knee ligament instability, ligament laxity, or meniscal instability of target knee.
Body mass index (BMI) > 40.
Active infection of a lower extremity (e.g. cellulitis).
Subjects with any clinical indication for arthroscopic surgery.
Obvious cartilage defects producing mechanical symptoms (i.e. locking).
Currently pregnant or new mothers who are breastfeeding.
Suspected meniscus injury, including a positive McMuray's test or significant joint line tenderness.
History of complete menisectomy.
Past or current history of peripheral vascular disease pertaining to the involved limb.
History of open knee surgery in affected knee or history of arthroscopic surgery in affected knee in past year.
Symptomatic bilateral knee OA (unless the contralateral knee involvement is limited to radiographic OA and not symptomatic).
Significant alignment deformity such as varus / valgus of target knee in the judgment of the investigator.
Known allergy to hylan G-F 20 or any of its components, or to avian proteins, eggs, feathers, down, or poultry.
Subjects with plans to initiate, cease or continue any other intra-articular knee joint injection during the course of the study.
Venous or lymphatic stasis in either leg.
Use of prohibited pain medications.
Known significant acute and / or concurrent medical comorbidities including, but not limited to current malignancy, history of transplant surgery, congestive heart failure, significant unstable cardiovascular disease, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, or neurological condition that in the judgment of the investigator would significantly impact life expectancy and / or the conduct of the trial.
Subjects currently prescribed chronic opioid analgesics at time of baseline visit that cannot be discontinued.
Prosthetic implant in either knee.
Concurrent multisystem or multilimb trauma.
Ipsilateral symptomatic OA of hip or ankle; contralateral symptomatic OA of hip, knee, or ankle, or clinical evidence of hip disease.
History of septic OA of any joint; and / or Inflammatory arthropathy such as RA (Rheumatoid Arthritis), gout, pseudogout, lupus, crystalline inflammatory arthropathy, chondrocalcinosis etc.
Isolated patellofemoral OA or isolated anterior knee pain (patellofemoral OA coexisting with tibiofemoral knee OA may be included).
Patellar tendonitis.
Female subjects interested in conceiving a child during the study period.

Locations

Weston, Florida, 33331
Weston, Florida, 33331

Tracking Information

NCT #
NCT02029703
Collaborators
Not Provided
Investigators
  • Principal Investigator: Elaine Husni, MD MPH The Cleveland Clinic
  • Elaine Husni, MD MPH The Cleveland Clinic