Amniotic Membrane in Total Knee Replacements to Reduce Scarring

Scarring Clinical Trial

Official title:

A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088567
• Other study ID #: AFTKR001
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: September 21, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Scarring

Intervention

Procedure:
• Total Knee Arthroplasty
Total knee arthroplasty, per the usual practice of the physician.

Other:
• Application 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

Locations

Country	Name	City	State
United States	Georgia Knee and Sports Medicine	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Increased Quality of Life as assessed by WOMAC and SF-36	Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life.	6 weeks	No
Primary	Increased range of motion between both groups as measured by goniometer		6 weeks	No
Secondary	Incidence of need for manual manipulation of affected knee		6 weeks	No