Amniotic Membrane in Total Knee Replacements to Reduce Scarring

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT02088567
First received: November 21, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Scarring
Procedure: Total Knee Arthroplasty
Other: Application of dHACM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Increased range of motion between both groups as measured by goniometer [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of need for manual manipulation of affected knee [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Increased Quality of Life as assessed by WOMAC and SF-36 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life.


Estimated Enrollment: 52
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088567

Contacts
Contact: Maurice Jove, MD (404) 296-5005

Locations
United States, Georgia
Georgia Knee and Sports Medicine Recruiting
Decatur, Georgia, United States, 30033
Principal Investigator: Maurice Jove, MD         
Sponsors and Collaborators
MiMedx Group, Inc.
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02088567     History of Changes
Other Study ID Numbers: AFTKR001
Study First Received: November 21, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014