Amniotic Membrane in Total Knee Replacements to Reduce Scarring
A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 23, 2015
September 1, 2015
9 months
November 21, 2013
September 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Increased range of motion between both groups as measured by goniometer
6 weeks
Secondary Outcomes (1)
Incidence of need for manual manipulation of affected knee
6 weeks
Other Outcomes (1)
Increased Quality of Life as assessed by WOMAC and SF-36
6 weeks
Study Arms (2)
dHACM
EXPERIMENTALTotal 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
Control
OTHERTotal knee arthroplasty, per the usual practice of the physician without application of dHACM.
Interventions
Total knee arthroplasty, per the usual practice of the physician.
Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia Knee and Sports Medicine
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Jove, MD
Georgia Knee and Sports Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
March 17, 2014
Study Start
January 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 23, 2015
Record last verified: 2015-09