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Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663036
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Centro Hospitalar Lisboa Ocidental
Information provided by (Responsible Party):
Clara Isabel de Campos Azevedo, Hospital de Egas Moniz

Brief Summary:

An irreparable rotator cuff tear (IRCT) is a challenge, with a controversial definition and different treatment options. None of the latter are exempt of limitations and their survivorship is one of the concerns. In 2013, Mihata et al. proposed a novel treatment option: arthroscopic superior capsular reconstruction using a fascia lata autograft (FL-ASCR) harvested through an open approach. Although no harvest site dysfunction was reported, concerns about donor site morbidity discouraged the use of this type of graft. In 2015, the investigators modified the original FL-ASCR introducing a minimally invasive fascia lata harvesting technique, aiming to reproduce FL-ASCR's promising clinical results in IRCT, while reducing donor site morbidity.

The investigators aim to: 1) Evaluate the mid-term outcomes and donor site morbidity impact of FL-ASCR with minimally invasive harvesting; 2) Analyze the mid-term graft integrity to determine its survivorship 3) Establish clinical and imaging graft integrity correlations to guide the future treatment algorithm.


Condition or disease Intervention/treatment Phase
Graft Failure Donor Site Complication Rotator Cuff Tear Diagnostic Test: Magnetic Resonance Imaging of the shoulder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic Superior Capsular Reconstruction With Minimally Invasive Harvested Fascia Lata Autograft - Clinical Outcomes and Survivorship of the Autograft Analysis
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : September 4, 2019
Actual Study Completion Date : September 4, 2019

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Arm Intervention/treatment
Experimental: FL-ASCR
Magnetic Resonance Imaging of the shoulder Radiograph of the shoulder
Diagnostic Test: Magnetic Resonance Imaging of the shoulder
Clinical and radiological assessments of the shoulders and the donor sites
Other Names:
  • Shoulder radiograph
  • Range of motion and strength measurements




Primary Outcome Measures :
  1. Shoulder outcomes of FL-ASCR with minimally invasive harvesting at 3 years postoperative [ Time Frame: 2 years ]
    Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5.). Bilateral functional shoulder scores: the simple shoulder test (SST, 1-12 points), the subjective shoulder value (SSV, 0-100%) and the constant score (CS, 1-100 points). Bilateral shoulder strength (supraspinatus, infraspinatus, subscapularis and teres minor, 0 -15 kg). For every scale range provided, higher values represent a better outcome.


Secondary Outcome Measures :
  1. Autograft mid-term survivorship at 3 years postoperative [ Time Frame: 2 years ]
    Analysis of the mid-term graft integrity on the 3-year postoperative magnetic resonance imaging (scale: 0 -1): 0 = graft absent or not healed to the greater tuberosity/superior glenoid; 1 = graft present and healed to the greater tuberosity and superior glenoid. For the scale range provided, higher values represent a better outcome.

  2. Fascia lata minimally invasive harvesting donor site morbidity impact at 3 years postoperative [ Time Frame: 2 years ]
    Three closed-ended questions to assess the donor site morbidity's impact on the patient's overall satisfaction of the surgical procedure will be asked to the participants: "Does the harvested thigh bother you?" (scale: , "Does your shoulder surgery's end result compensate for your thigh's changes?" (scale: 0 - 1; 0 = no, 1 = yes), "Would you undergo the same surgery again?" (scale: 0 - 1; 0 = no, 1 = yes). The participants will be asked, in a closed-ended questionnaire, if they noticed any of the following donor site changes: deformity (scale: 0 - 1; 0 = no, 1 = yes), pain (scale: 0 -1; 0 = no, 1 = yes), numbness (scale: 0 - 1; 0 = no, 1 = yes)and specific donor site-related claudication (scale: 0 -1; 0 = no, 1 = yes). For every scale range provided, higher values represent a better outcome.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FL-ASCR by the same surgeon (principal investigator) since 2015
  • completed the preoperative and the 6 months postoperative clinical, radiological and MRI assessments

Exclusion Criteria:

  • secondary surgery for the removal of the implanted autograft in the shoulder which had previously ungergone the FL-ASCR procedure
  • secondary surgery to the harvested thigh

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): NCT03663036


Locations
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Portugal
Centro Hospitalar de Lisboa Ocidental
Lisboa, Portugal, 1700-348
Sponsors and Collaborators
Clara Isabel de Campos Azevedo
Centro Hospitalar Lisboa Ocidental
Investigators
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Principal Investigator: Clara IC Azevedo, MD Centro Hospitalar de Lisboa Ocidental
Publications:
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Responsible Party: Clara Isabel de Campos Azevedo, Shoulder Surgery Unit Coordinator, Hospital de Egas Moniz
ClinicalTrials.gov Identifier: NCT03663036    
Other Study ID Numbers: 01-2018-07HSFX
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clara Isabel de Campos Azevedo, Hospital de Egas Moniz:
Arthroscopic Superior Capsular Reconstruction
Fascia Lata
Autograft
Donor Site Morbidity
Rotator Cuff Tear
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries