Amniotic Membrane in Total Knee Replacements to Reduce Scarring

Not Applicable

Completed

• Conditions: Scarring
• Interventions: Procedure: Total Knee Arthroplasty; Other: Application of dHACM

• Registration Number: NCT02088567
• Lead Sponsor: MiMedx Group, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study Start: 2014-01
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Total Knee Arthroplasty	Total knee arthroplasty, per the usual practice of the physician without application of dHACM.
dHACM	Total Knee Arthroplasty	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
dHACM	Application of dHACM	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

Primary Outcome Measures

Name	Time	Method
Increased range of motion between both groups as measured by goniometer	6 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of need for manual manipulation of affected knee	6 weeks

Trial Locations

Locations (1)

Georgia Knee and Sports Medicine; 🇺🇸 Decatur, Georgia, United States