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Amniotic Membrane in Total Knee Replacements to Reduce Scarring

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ClinicalTrials.gov Identifier: NCT02088567
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Study Description
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Brief Summary:
The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.

Condition or disease Intervention/treatment Phase
Scarring Procedure: Total Knee Arthroplasty Other: Application of dHACM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: dHACM
Total knee arthroplasty, per the usual practice of the physician with application of dHACM between the underlying fascia and the overlying skin layers to reduce scar formation
 Procedure: Total Knee Arthroplasty
Total knee arthroplasty, per the usual practice of the physician.

Other: Application of dHACM
Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation
Control
Total knee arthroplasty, per the usual practice of the physician without application of dHACM.
 Procedure: Total Knee Arthroplasty
Total knee arthroplasty, per the usual practice of the physician.


Outcome Measures
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Primary Outcome Measures :
  1. Increased range of motion between both groups as measured by goniometer [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Incidence of need for manual manipulation of affected knee [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. Increased Quality of Life as assessed by WOMAC and SF-36 [ Time Frame: 6 weeks ]
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are adults ages 18 or older.
  2. Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
  3. Have a willingness to comply with follow-up examination.
  4. Have ability to give full written consent.

Exclusion Criteria:

  1. Has had a previous total or partial joint replacement performed at the same site
  2. Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
  3. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
  4. Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
  5. Is pregnant or may become pregnant during the study.
  6. Is a prisoner.
  7. Has any condition(s) which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment.
  8. Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
  9. Is confined to bed or a wheelchair.
  10. Has clinical signs and symptoms of local infection at the site.
  11. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
  12. Has current diagnosis of cancer at the site.
  13. Has had prior radiation therapy treatment at the site.
  14. Is currently taking anticoagulant therapy.
  15. Is unable to sign or understand informed consent.
  16. Has a history of drug or alcohol abuse within last 12 months.
  17. Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
Contacts and Locations
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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): NCT02088567


Locations
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United States, Georgia
Georgia Knee and Sports Medicine
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
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Principal Investigator: Maurice Jove, MD Georgia Knee and Sports Medicine
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02088567    
Other Study ID Numbers: AFTKR001
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes