Rotator Cuff Tear Clinical Trial
Official title:
Arthroscopic Superior Capsular Reconstruction With Minimally Invasive Harvested Fascia Lata Autograft - Clinical Outcomes and Survivorship of the Autograft Analysis
Verified date | September 2019 |
Source | Hospital de Egas Moniz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | September 4, 2019 |
Est. primary completion date | September 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Portugal | Centro Hospitalar de Lisboa Ocidental | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Clara Isabel de Campos Azevedo | Centro Hospitalar Lisboa Ocidental |
Portugal,
Ângelo ACLPG, de Campos Azevedo CI. Minimally invasive fascia lata harvesting in ASCR does not produce significant donor site morbidity. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):245-250. doi: 10.1007/s00167-018-5085-1. Epub 2018 Aug 1. — View Citation
de Campos Azevedo CI, Ângelo ACLPG, Vinga S. Arthroscopic Superior Capsular Reconstruction With a Minimally Invasive Harvested Fascia Lata Autograft Produces Good Clinical Results. Orthop J Sports Med. 2018 Nov 27;6(11):2325967118808242. doi: 10.1177/2325967118808242. eCollection 2018 Nov. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder outcomes of FL-ASCR with minimally invasive harvesting at 3 years postoperative | 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. | 2 years | |
Secondary | Autograft mid-term survivorship at 3 years postoperative | 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 years | |
Secondary | Fascia lata minimally invasive harvesting donor site morbidity impact at 3 years postoperative | 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. | 2 years |
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