Amniotic Membrane in Total Knee Replacements to Reduce Scarring

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).