Amniotic Membrane in Total Knee Replacements to Reduce Scarring

MiMedx

Status: Completed

Conditions: Scarring

Treatments: Other: Application of dHACM; Procedure: Total Knee Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT02088567

AFTKR001

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

dHACM

Experimental group

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

Treatment:

Other: Application of dHACM

Procedure: Total Knee Arthroplasty

Control

Other group

Description:

Total knee arthroplasty, per the usual practice of the physician without application of dHACM.

Treatment:

Procedure: Total Knee Arthroplasty