ScarringNCT02088567
Amniotic Membrane in Total Knee Replacements to Reduce Scarring
A study testing Total Knee Arthroplasty and Application of dHACM in people with Scarring, run by MiMedx Group, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring
- What is being tested?
- Total Knee Arthroplasty and Application of dHACM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are adults ages 18 or older.
- Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
- Have a willingness to comply with follow-up examination.
- Have ability to give full written consent.
Who cannot join
- Has had a previous total or partial joint replacement performed at the same site
- Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
- Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
- Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- Is pregnant or may become pregnant during the study.
- Is a prisoner.
Show all 17Show fewer
- 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.
- Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
- Is confined to bed or a wheelchair.
- Has clinical signs and symptoms of local infection at the site.
- Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- Has current diagnosis of cancer at the site.
- Has had prior radiation therapy treatment at the site.
- Is currently taking anticoagulant therapy.
- Is unable to sign or understand informed consent.
- Has a history of drug or alcohol abuse within last 12 months.
- Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Knee and Sports Medicine
Decatur, Georgia, 30033
About this study
Official title: 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.
- Conditions
- Scarring
- Being tested
- Total Knee Arthroplasty, Application of dHACM
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Total knee arthroplasty, per the usual practice of the physician.
Application of dHACMOther
Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | 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 Receives: Procedure: Total Knee Arthroplasty; Other: Application of dHACM |
| Control | Other | Total knee arthroplasty, per the usual practice of the physician without application of dHACM. Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased range of motion between both groups as measured by goniometer
Measured: 6 weeks
Secondary outcomes (1)
Incidence of need for manual manipulation of affected knee
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Jove, MD, Principal investigator, Georgia Knee and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088567
- Sponsor's protocol ID
- AFTKR001
- Status last verified
- Sep 2015
- First submitted
- 21 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.
- ClinicalTrials.gov ID
- NCT02088567
- Acronym / sponsor ID
- AFTKR001
- Conditions
- Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Procedure: Total Knee Arthroplasty, Other: Application of dHACMTotal 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 |
| Control | Other | Procedure: Total Knee ArthroplastyTotal knee arthroplasty, per the usual practice of the physician without application of dHACM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are adults ages 18 or older.
- Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
- Have a willingness to comply with follow-up examination.
- Have ability to give full written consent.
Key exclusion criteria (17 listed)
- Has had a previous total or partial joint replacement performed at the same site
- Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
- Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
- Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- Is pregnant or may become pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastyTotal knee arthroplasty, per the usual practice of the physician. | Procedure or surgery | Control, dHACM |
| Application of dHACMApplication of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation | Other | dHACM |
Primary outcome
Increased range of motion between both groups as measured by goniometer
Time frame: 6 weeks
1 secondary outcome
Incidence of need for manual manipulation of affected knee
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Jove, MD principal investigator
Georgia Knee and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty and Application of dHACM in people with Scarring, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased range of motion between both groups as measured by goniometer (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.