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Non-Ablative Fractional Resurfacing of Total Knee Replacement Scars

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ClinicalTrials.gov Identifier: NCT02166138
Recruitment Status : Unknown
Verified March 2015 by Charles Cornell, MD, Hospital for Special Surgery, New York.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Charles Cornell, MD, Hospital for Special Surgery, New York

Brief Summary:
The condition to be studied is post-surgical scarring following primary total knee replacement, specifically whether fractional non-ablative laser therapy can be used to significantly decrease the morbidity of scarring.

Condition or disease Intervention/treatment Phase
Epidermal Thickening, Unspecified Procedure: Non-Abilative Laser treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Non-Ablative Fractional Resurfacing of Total Knee Replacement Scars
Study Start Date : November 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laser treated Group
Patients in this group will be given the laser treatment with the non-abilative 1540 nm wavelength. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits. Thus, patients in this group will be getting the Non-Abilative laser treatment.
Procedure: Non-Abilative Laser treatment
Patients in this group will be given the laser treatment with the non-abilative 1540 nm wavelength. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits.
Other Name: Laser treated group

Placebo Comparator: Not Laser treated Group
Patients in this group will be given the laser treatment with the 1540 non-abilative laser device, but the device will not be set to provide treatment. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits.



Primary Outcome Measures :
  1. The change in POSAS scores between patients in the laser treated group and the not laser treated group at 4 weeks, 8 weeks, 3 month, and 1 year follow up visits. [ Time Frame: 4 week, 8 week, 3 month, and 1 year follow up visits ]

    The primary outcome will be the difference in patient reported POSAS score between those patients that received laser therapy and those who did not receive laser therapy. The POSAS will be collected at the 4 week, 8 week, 3 month and 12 month time points.

    The POSAS consists of two scales: the patient scale and the observer scale. Both scales consist of six items that are scored numerically. The six items on the observer scale are: scar vascularity, pigmentation, pliability, thickness, relief and surface area. The six items scored by patients are: pain, itching, color, pliability, thickness and relief. Each of the six items is scored from 1-10 with 10 indicating the worst imaginable scar outcome. Each of the scores for the six items is added up for a cumulative score between 6 and 60 where 6 represents normal skin and 60 represents the worst scar imaginable. Both the patient and observer scale have been found to be reliable and valid in the evaluation of linear, surgical scars.



Secondary Outcome Measures :
  1. KOOS [ Time Frame: 4 week, 8 week, 3 month, and 1 year follow up visits ]

    Secondary outcomes include the difference in Knee injury and Osteoarthritis Outcome Score KOOS score at 4 week, 8 week, 3 months and 1 year between the treated and untreated groups. Additionally, any data collected at routine follow-ups will be collected and analyzed. This includes baseline demographic information as well as physical exam findings, including pre-operative and post-operative knee range of motion (ROM).

    The KOOS adopted the Western Ontario and McMaster Universities Arthritis Index and added two additional subscales to evaluate knee function after ligament, articular cartilage, or meniscal injury, and their respective treatments. The KOOS proved to be a patient-oriented outcome measure and demonstrated test-retest reliability and internal consistency. It was found to be more responsive than the WOMAC and SF-36, and validation was performed for face, content, criterion, concurrent, construct and convergent validity.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients will be included if:

    • They are indicated for primary total knee replacement
    • Have no history of wound healing problems, chronic infection, or known skin or connective tissue disease.
    • Are 18 years of age or older
    • Have a skin type classified as a Fitzpatrick type I-VI.

Exclusion Criteria:

  • Patients will be excluded for the following reasons:

    • Any prior history of surgery on their knee
    • Mental or psychological illness that prohibits the patient from completing the necessary forms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166138


Contacts
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Contact: Shivi Duggal, BS,MBA 2126061414 duggals@hss.edu
Contact: Charles N. Cornell, MD 2126061414 cornellc@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
NY, New York, United States, 10021
Contact: Shivi Duggal, BS,MBA    212-606-1414    duggals@hss.edu   
Principal Investigator: Charles N. Cornell, MD         
Sub-Investigator: M. Michael Khair, MD         
Sub-Investigator: Shivi Duggal, BS,MBA         
Sub-Investigator: Natalie Trezza, RN         
Sub-Investigator: Kenneth Rothaus, MD         
Sponsors and Collaborators
Charles Cornell, MD
Investigators
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Principal Investigator: Charles N. Cornell, MD Hospital for Special Surgery, New York
Publications:
Fitzpatrick TB. Soleil et peau. J Med Esthet 1975;2:33-4.

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Responsible Party: Charles Cornell, MD, MD, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02166138    
Other Study ID Numbers: 13045
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015