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Clinical Trials/NCT03663036
NCT03663036CompletedNot Applicable

Arthroscopic Superior Capsular Reconstruction With Minimally Invasive Harvested Fascia Lata Autograft - Clinical Outcomes and Survivorship of the Autograft Analysis

Clara Isabel de Campos Azevedo1 site in 1 country21 target enrollmentStarted: September 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
1
Primary Endpoint
Shoulder outcomes of FL-ASCR with minimally invasive harvesting at 3 years postoperative

Study Overview

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.

Detailed Description

Task 1 - Prospective evaluation of:

  1. The mid-term shoulder outcomes of ASCR with minimally invasive harvested fascia lata autograft The objective of this task is to establish the 3 years postoperative clinical and radiological shoulder outcomes of FL-ASCR with minimally invasive harvesting. The secondary purpose of this task is to test if the FL-ASCR outcomes remain constant after the 2-year evaluation.

Therefore, the FL-ASCR patients included in this study will have completed the preoperative, 6-month and 2-year postoperative evaluations and will undergo a 3-year postoperative evaluation of:

  1. Bilateral shoulder active range of motion (ROM): elevation, abduction and external rotation (with the arm at the side), measured in degrees with the use of an analogic goniometer; 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.);
  2. Bilateral shoulder strength (supraspinatus, infraspinatus, subscapularis and teres minor) measured in kilograms with the use of a digital dynamometer;
  3. 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).
  4. True anteroposterior shoulder view radiograph of the affected shoulder: the acromiohumeral interval (AHI), considering the distance between the top of the humeral head and the undersurface of the acromion, measured using a software measurement tool (PACS, Agfa HealthCare); the RCT arthritis will be graded according to the Hamada revised radiographic classification.
  5. The donor site morbidity impact of FL-ASCR with minimally invasive harvesting The objective of this task is to establish the 3-year donor site morbidity subjective impact of FL-ASCR with minimally invasive harvesting. The secondary aim of this task is to test our hypothesis that the subjective impact of the donor site morbidity after FL-ASCR does not change significantly from the 2-year to the 3-year evaluation. Therefore, at the 3-year evaluation, the patients will be required to answer to the same three closed-ended questions that were asked at the 2-year evaluation to assess the donor site morbidity's impact on the patient's overall satisfaction of the surgical procedure: "Does the harvested thigh bother you?", "Does your shoulder surgery's end result compensate for your thigh's changes?", "Would you undergo the same surgery again?". Accordingly, the patients will also be asked asked, in a closed-ended questionnaire, if they noticed any of the following donor site changes: deformity, pain, numbness and specific donor site-related claudication.

Task 2 - Analysis of the mid-term graft integrity on the 3-year postoperative magnetic resonance imaging (MRI) to determine the graft mid-term survivorship

The objective of this task is to determine the 3-year postoperative survivorship of the graft, establishing the fascia lata superior capsular graft tearing rate and the most frequent site of graft failure at 3 years. A 1.5 Tesla MRI scanner (Siemens Magnetom, U.S.A.) will be used to acquire images in the coronal [proton density fat-saturated (PD FAT-SAT) and T1-weighted], sagittal (PD FAT-SAT and T2 FAT-SAT) and axial (T2* and PD) planes. We and, after blinding, two other independent experienced musculoskeletal radiologists will assess the MRI-images from each patient, in order to:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

FL-ASCR

Experimental

Magnetic Resonance Imaging of the shoulder Radiograph of the shoulder

Intervention: Magnetic Resonance Imaging of the shoulder (Diagnostic Test)

Outcomes

Primary Outcomes

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 Outcomes

  • Autograft mid-term survivorship at 3 years postoperative(2 years)
  • Fascia lata minimally invasive harvesting donor site morbidity impact at 3 years postoperative(2 years)

Investigators

Sponsor
Clara Isabel de Campos Azevedo
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Clara Isabel de Campos Azevedo

Shoulder Surgery Unit Coordinator

Hospital de Egas Moniz

Study Sites (1)

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