Scarring
Conditions
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.
Interventions
PROCEDURETotal Knee Arthroplasty
Total knee arthroplasty, per the usual practice of the physician.
OTHERApplication 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
Sponsors
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased range of motion between both groups as measured by goniometer | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of need for manual manipulation of affected knee | 6 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Increased Quality of Life as assessed by WOMAC and SF-36 | 6 weeks | Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life. |
Countries
United States
Outcome results
None listed