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Optimization of Synvisc-One for Knee OA

This study has been terminated.
(Enrollment Goals not met)
Sponsor:
Information provided by (Responsible Party):
Elaine Husni, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT02029703
First received: January 6, 2014
Last updated: March 10, 2017
Last verified: March 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider;   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Device: Synvisc-One Injection
Other: Sham Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sham Injection

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.

Sham Injection

Synvisc-One Injection

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.

Synvisc-One Injection


Participant Flow:   Overall Study
    Sham Injection   Synvisc-One Injection
STARTED   20   22 
COMPLETED   20   22 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sham Injection

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.

Sham Injection

Synvisc-One Injection

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.

Synvisc-One Injection

Total Total of all reporting groups

Baseline Measures
   Sham Injection   Synvisc-One Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   22   42 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (13.4)   59.2  (10.2)   60.1  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  70.0%      17  77.3%      31  73.8% 
Male      6  30.0%      5  22.7%      11  26.2% 
Number of Participants 
[Units: Participants]
Count of Participants
 20   22   42 


  Outcome Measures

1.  Primary:   Difference in Pain Score Between Groups   [ Time Frame: 12 and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: M. Elaine Husni, MD, MPH
Organization: Cleveland Clinic
phone: 216-445-1853
e-mail: HUSNIE@CCF.ORG



Responsible Party: Elaine Husni, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT02029703     History of Changes
Other Study ID Numbers: CC-GENZYME-2012
Study First Received: January 6, 2014
Results First Received: January 18, 2017
Last Updated: March 10, 2017