Back to resultsAmniotic Membrane in Total Knee Replacements to Reduce Scarring
Primary Purpose
Scarring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty
Application of dHACM
Sponsored by
About this trial
This is an interventional treatment trial for Scarring
Eligibility Criteria
Inclusion Criteria:
- Are adults ages 18 or older.
- Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
- Have a willingness to comply with follow-up examination.
- Have ability to give full written consent.
Exclusion Criteria:
- Has had a previous total or partial joint replacement performed at the same site
- Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
- Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
- Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- Is pregnant or may become pregnant during the study.
- Is a prisoner.
- 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.
- Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
- Is confined to bed or a wheelchair.
- Has clinical signs and symptoms of local infection at the site.
- Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Has current diagnosis of cancer at the site.
- Has had prior radiation therapy treatment at the site.
- Is currently taking anticoagulant therapy.
- Is unable to sign or understand informed consent.
- Has a history of drug or alcohol abuse within last 12 months.
- Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
Sites / Locations
- Georgia Knee and Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
dHACM
Control
Arm Description
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
Total knee arthroplasty, per the usual practice of the physician without application of dHACM.
Outcomes
Primary Outcome Measures
Increased range of motion between both groups as measured by goniometer
Secondary Outcome Measures
Incidence of need for manual manipulation of affected knee
Full Information
NCT ID
NCT02088567
First Posted
November 21, 2013
Last Updated
September 21, 2015
Sponsor
MiMedx Group, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02088567
Brief Title
Amniotic Membrane in Total Knee Replacements to Reduce Scarring
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dHACM
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
Total knee arthroplasty, per the usual practice of the physician without application of dHACM.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty
Intervention Description
Total knee arthroplasty, per the usual practice of the physician.
Intervention Type
Other
Intervention Name(s)
Application of dHACM
Intervention Description
Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation
Primary Outcome Measure Information:
Title
Increased range of motion between both groups as measured by goniometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Incidence of need for manual manipulation of affected knee
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Increased Quality of Life as assessed by WOMAC and SF-36
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are adults ages 18 or older.
Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
Have a willingness to comply with follow-up examination.
Have ability to give full written consent.
Exclusion Criteria:
Has had a previous total or partial joint replacement performed at the same site
Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
Is pregnant or may become pregnant during the study.
Is a prisoner.
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.
Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
Is confined to bed or a wheelchair.
Has clinical signs and symptoms of local infection at the site.
Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
Has current diagnosis of cancer at the site.
Has had prior radiation therapy treatment at the site.
Is currently taking anticoagulant therapy.
Is unable to sign or understand informed consent.
Has a history of drug or alcohol abuse within last 12 months.
Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Jove, MD
Organizational Affiliation
Georgia Knee and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Knee and Sports Medicine
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
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Amniotic Membrane in Total Knee Replacements to Reduce Scarring
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