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The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy

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ClinicalTrials.gov Identifier: NCT02640144
Recruitment Status : Unknown
Verified January 2017 by Noam Reshef, Ziv Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 28, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Noam Reshef, Ziv Medical Center

Brief Summary:

This is a prospective, double blind randomized controlled trial. In this study we will investigate the influence of hyaluronic acid injection to knee after knee arthroscopy, when known or discovered cartilage damage greater than International Cartilage Research Society score (ICRS) grade 2 is found. The indication for arthroscopy is not necessarily the cartilage damage. A set of 3 consecutive injections will be administered and follow up of physical examination and questionaries will be done.

Our null hypothesis is that the administration of hyaluronic acid will show decrease pain and quicker rehabilitation and return to normal activity in patients with grade 2 and higher cartilage damage that had gone through knee arthroscopy.


Condition or disease Intervention/treatment Phase
Cartilage Damage Drug: Sodium Hyaluronate 1% Drug: Placebo Phase 4

Detailed Description:

The use of hyaluronic acid is well known as one of the treatment modalities for knee osteoarthritis (OA) .Arthroscopy is a controversial treatment option for knee OA but in some cases, during knee arthroscopy done for other indication, cartilage damage is noted. This cartilage damage may slower the healing and rehabilitation process after knee arthroscopy. Therefore we will evaluate the influence of hyaluronic acid injection on the healing and rehabilitation process following knee arthroscopy.

All patients will be recruited prior to the arthroscopy. All patients will sign a concent form.Patients will be randomly divided to 2 groups which are the 2 arms of this study - treatment group and control group. All patient will be examined by a senior orthopedic surgeon and will fill the pre operative questionnaires. MRI scan of the operated knee prior for the surgery will be collected and evaluated.Knee arthroscopy will be performed by 2 senior orthopedic surgeons. Data and arthroscopic findings will be collected and documented during surgery. 2 weeks after surgery patients will be evaluated in the hospitals' outpatients clinic. The treatment group will be given a series of 3 injections of Sodium Hyaluronate 1%(ARTHREASE, TM) - one injection per week. The control group will be given a series of 3 injections of placebo (BPS - Buffer Phosphate Solution - the buffer solution of the hyaluronic acid regular injections). The syringes will be blinded to the patients and the physician.

questionnaires will be given at 2 weeks, 6 weeks, 3months and 6 months post operatively

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment group
Randomized, patients that are going for knee arthroscopy for any indication including pain and cartilage damage or osteoarthritis. After surgery - will receive 3 injections of Sodium Hyaluronate 1% - ARTHREASE TM
Drug: Sodium Hyaluronate 1%
Intra articular knee injection following arthroscopy
Other Names:
  • ARTHREASE
  • Euflexxa

Placebo Comparator: Control group
Randomized, patients that are going for knee arthroscopy for any indication including pain and cartilage damage or osteoarthritis. After surgery - will receive 3 injections of BPS - Buffer Phosphate Solution - as a placebo
Drug: Placebo
Intra articular knee injection following knee arthroscopy. Serves as a placebo. This is the actual buffer of the ARTHREASE injection.
Other Name: BPS = Buffer Phosphate Solution




Primary Outcome Measures :
  1. Pain reduction [ Time Frame: up to 6 month ]
    The treatment group will show lower scores than control group at all checkpoints- 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluated using Visual Analog Scale (VAS) for pain

  2. Change in the International Knee Documentation Committee (IKDC) score as a measure of Return to normal activity [ Time Frame: up to 6 month ]
    The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is using the International Knee Documentation Committee (IKDC) score

  3. Change in the knee circumference as a measure for Knee swelling [ Time Frame: up to 6 month ]
    The treatment group will show less episodes of knee swelling than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Will be evaluated by measuring the knee circumference using a simple measuring tape in centimeters.

  4. Change in "Tegner-Lysholm" score as a measure of better function [ Time Frame: up to 6 month ]
    The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is "Tegner - Lysholm" score

  5. Change in the Short Form (SF) 12 score as a measure of return to normal activity [ Time Frame: up to 6 months ]
    The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is using Short Form (SF)-12 score.

  6. Subjective description of return to normal activity as described by patients [ Time Frame: up to 6 months ]
    The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is subjective by patients description.

  7. Change in the "Tegner-Lysholm" score as a measure of return to normal activity [ Time Frame: up to 6 months ]
    The treatment group will show quicker return to normal activity that control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Evaluation is subjective by using "Tegner - Lysholm" score

  8. Subjective change in knee swelling [ Time Frame: up to 6 months ]
    The treatment group will show less episodes of knee swelling than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively. Will be evaluated subjectively by the patients description.

  9. Change in Short Form(SF) 12 score as a measure of better function [ Time Frame: up to 6 months ]
    The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is Short-Form (SF)12 score

  10. Change in the International Knee Documentation Committee (IKDC) score as a measure of better function [ Time Frame: up to 6 months ]
    The treatment group will show better scores in all functional questionnaires than the control group at all checkpoints - 2 weeks post operatively, 6 weeks post operatively, 3 months post operatively and 6 months post operatively.The questionnaires that will be used is International Knee Documentation Committee (IKDC) score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years old
  • signing a concent form
  • Assigned for knee arthroscopy.
  • Known chondral lesion of at least ICRS grade 2 in one or mor of the knee compartments per MRI prior to knee arthroscopy.
  • Cartilage lesion of at least ICRS grade 2 in one or mor of the knee compartments that was found during the knee arthroscopy.

Exclusion Criteria:

  • Rheumatic disease
  • Synovial disease such as (but not limited to) Pigmented ViloNodular synovitis (PVNS)
  • Infection of the operated knee - new or previous
  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640144


Contacts
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Contact: Noam Reshef, MD +972-54-5523454 noamreshefmd@gmail.com
Contact: Rinat Elizur, Prod. mnger +972-54-3009512

Sponsors and Collaborators
Ziv Medical Center
Investigators
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Principal Investigator: Noam Reshef, MD Ziv Medical Center, Zefat, Israel

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Original study protocol is written in Hebrew. protocol is available at the Ziv Medical Center, Institutional Review Board (IRB) , or in direct request via the website address posted above.

Publications of Results:
Other Publications:
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Responsible Party: Noam Reshef, Attending Orthopedic Surgeon, Orthopedic Sports specialist, Ziv Medical Center
ClinicalTrials.gov Identifier: NCT02640144    
Other Study ID Numbers: 0013-15-ZIV
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Noam Reshef, Ziv Medical Center:
Hyaluronic acid
Knee arthroscopy
pain reduction
swelling
osteoarthritis
cartilage lesion
rehabilitation following knee arthroscopy
Hyaluronic acid injection
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents