Amniotic Membrane in Total Knee Replacements to Reduce Scarring

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

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

Study Overview

• Status: Completed
• Conditions: Scarring
• Intervention / Treatment: Procedure: Total Knee Arthroplasty; Other: Application of dHACM

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Georgia Knee and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Other: Control; Total knee arthroplasty, per the usual practice of the physician without application of dHACM.	Procedure: Total Knee Arthroplasty; Total knee arthroplasty, per the usual practice of the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increased range of motion between both groups as measured by goniometer	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of need for manual manipulation of affected knee	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Maurice Jove, MD, Georgia Knee and Sports Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: AFTKR001