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
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.
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.
2. 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:
1. Identify any discontinuity of the graft which, if present, will be classified according
to its site as a proximal, an intermediate or a distal tear; and as an anterior or a
posterior tear.
2. Identify any discontinuity of the onlay repair of the rotator cuff remnants, which, if
present, will be classified a tear of the onlay repair.
3. Grade the supraspinatus, infraspinatus, teres minor and subscapularis muscle fatty
degeneration according to the Goutallier et al. classification.
4. Grade the RCT tendon remnants retraction in the coronal plane according to the Patte
classification.
5. Grade the supraspinatus muscle atrophy according to the Thomazeau et al. classification.
6. Grade the supraspinatus muscle atrophy according to the tangent sign. The graft
survivorship according to the three separate evaluations will be compared to establish
the inter-observer reliability of the MRI graft survivorship results.
The type of progression of graft integrity will be determined by comparing the 6-month with
the 3-year MRI evaluation of the graft survivorship.
Task 3 - Comparative analysis of the clinical, radiological and MRI preoperative and
postoperative variables
The objective of this task is to find correlations between the graft survivorship and the
results from tasks 1 and 2. The aim is to establish the clinical importance of mid-term graft
survivorship.
The investigators will compare the ROM, shoulder strength, SSV, SST, CS and AHI from
preoperative to 3 years postoperative; and from 2 years postoperative to 3 years
postoperative (paired-samples t-test). The investigators will compare all continuous
variables between the group of ASCR patients who underwent an additional onlay partial RCT
repair and the group that underwent ASCR without an onlay partial RCT repair, between the
anterior acromioplasty-ASCR group and the group that did not undergo an anterior
acromioplasty, between the tenotomy-ASCR group and the no-LHBT group, between the
preoperative and postoperative AHI<7mm group and the AHIā„7mm group, and between the
intact-graft group and the graft-tear group (Mann-Whitney U test). The investigators will
compare all categorical variables, including the donor site morbidity and overall subjective
outcome results, between the groups (Fisher's exact test).
To determine the repercussion of FL-ASCR and of the graft integrity on the rotator cuff
muscle function the investigators will compare the progression of the Goutallier
classification of each rotator cuff muscle from preoperative to 3 years postoperative, as
well as the cumulative Goutallier score (the sum of the fatty infiltration stages of the four
muscles) and the global fatty muscle degeneration index (the mean value of the grades for the
supraspinatus, infraspinatus, and subscapularis), between the intact-graft group and the
graft-tear group.
A significant difference will be defined as P<0.05.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Suspended |
NCT03290196 -
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
|
Phase 4 | |
Active, not recruiting |
NCT03091075 -
Oxandrolone Rotator Cuff Trial
|
N/A | |
Completed |
NCT03380533 -
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
|
Phase 2/Phase 3 | |
Completed |
NCT04566939 -
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
|
||
Active, not recruiting |
NCT02716441 -
Rotator Cuff Failure With Continuity
|
||
Completed |
NCT03540030 -
Opioid-Free Shoulder Arthroplasty
|
Phase 4 | |
Completed |
NCT02298023 -
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
|
Phase 2 | |
Completed |
NCT02850211 -
A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair
|
Phase 4 | |
Completed |
NCT01383239 -
Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
|
N/A | |
Completed |
NCT01459536 -
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
|
N/A | |
Completed |
NCT01204606 -
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
|
N/A | |
Completed |
NCT01170312 -
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
|
N/A | |
Terminated |
NCT00936559 -
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
|
Phase 1 | |
Completed |
NCT00852657 -
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
|
N/A | |
Active, not recruiting |
NCT00182299 -
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
|
Phase 4 | |
Recruiting |
NCT06120998 -
Quality of Life After Arthroscopic Rotator Cuff Repair
|
||
Completed |
NCT05897866 -
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
|
N/A | |
Completed |
NCT02644564 -
Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
|
N/A | |
Withdrawn |
NCT03739749 -
Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts
|
N/A |