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CompletedNCT02088567Updated Sep 23, 2015

Amniotic Membrane in Total Knee Replacements to Reduce Scarring

An interventional study of Total Knee Arthroplasty and Application of dHACM in Scarring, sponsored by MiMedx Group, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by MiMedx Group, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Scarring

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03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's enrollment of 52 is above the median of 39 across 251 interventional studies indexed under Cicatrix.

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Lead sponsor

MiMedx Group, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • 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 · Other: Application of dHACM

  • Other
    Control

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

    Procedure: Total Knee Arthroplasty

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

06

What researchers measure

Primary outcomes

  1. Increased range of motion between both groups as measured by goniometer

    Time frame: 6 weeks

Secondary outcomes

  1. Incidence of need for manual manipulation of affected knee

    Time frame: 6 weeks

Other outcomes

  1. 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.

    Time frame: 6 weeks

07

Study locations

1 site
  • Georgia Knee and Sports Medicine
    Decatur, Georgia 30033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02088567
Lead sponsor
MiMedx Group, Inc.
Responsible party
Sponsor
First posted
Mar 17, 2014
Start date
Jan 2014
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Sep 23, 2015

Study contacts

Maurice Jove, MD
principal investigator · Georgia Knee and Sports Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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