Graft FailureNCT03663036
Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis
A study testing Magnetic Resonance Imaging of the shoulder in people with Graft Failure and Donor Site Complication, run by Clara Isabel de Campos Azevedo at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft Failure, Donor Site Complication, Rotator Cuff Tear
- What is being tested?
- Magnetic Resonance Imaging of the shoulder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Sep 2018to 4 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FL-ASCR by the same surgeon (principal investigator) since 2015
- completed the preoperative and the 6 months postoperative clinical, radiological and MRI assessments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Task 1 - Prospective evaluation of:
- 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:
- 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.);
- Bilateral shoulder strength (supraspinatus, infraspinatus, subscapularis and teres minor) measured in kilograms with the use of a digital dynamometer;
- 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).
- 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.
- 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:
- 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.
- Identify any discontinuity of the onlay repair of the rotator cuff remnants, which, if present, will be classified a tear of the onlay repair.
- Grade the supraspinatus, infraspinatus, teres minor and subscapularis muscle fatty degeneration according to the Goutallier et al. classification.
- Grade the RCT tendon remnants retraction in the coronal plane according to the Patte classification.
- Grade the supraspinatus muscle atrophy according to the Thomazeau et al. classification.
- 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 AHI≥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.
- Conditions
- Graft Failure, Donor Site Complication, Rotator Cuff Tear
- Being tested
- Magnetic Resonance Imaging of the shoulder
- Keywords
- Arthroscopic Superior Capsular Reconstruction, Fascia Lata, Autograft, Donor Site Morbidity, Rotator Cuff Tear
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging of the shoulderDiagnostic test
Also called Shoulder radiograph, Range of motion and strength measurements
Clinical and radiological assessments of the shoulders and the donor sites
| Study group | Role | What they receive |
|---|---|---|
| FL-ASCR | Experimental | Magnetic Resonance Imaging of the shoulder Radiograph of the shoulder Receives: Diagnostic Test: Magnetic Resonance Imaging of the shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start5 Sep 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clara Isabel de Campos Azevedo
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental
- Responsible party
- Sponsor-investigator, Clara Isabel de Campos Azevedo, Hospital de Egas Moniz
- Investigators
- Clara IC Azevedo, MD, Principal investigator, Centro Hospitalar de Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663036
- Sponsor's protocol ID
- 01-2018-07HSFX
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Campos Azevedo CI, Angelo 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.
PubMed 30505873Angelo 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.
PubMed 30069653Azevedo CIC, Catarina Leiria Pires Gago Angelo A, Campos-Correia D, Delgado L, Ferreira N, Sevivas N. Clinical Importance of Graft Integrity in Arthroscopic Superior Capsular Reconstruction Using a Minimally Invasively Harvested Midthigh Fascia Lata Autograft: 3-Year Clinical and Magnetic Resonance Imaging Outcomes. Am J Sports Med. 2020 Jul;48(9):2115-2128. doi: 10.1177/0363546520928649.
PubMed 32667265
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Superior Capsular Reconstruction With Minimally Invasive Harvested Fascia Lata Autograft - Clinical Outcomes and Survivorship of the Autograft Analysis
- ClinicalTrials.gov ID
- NCT03663036
- Acronym / sponsor ID
- 01-2018-07HSFX
- Conditions
- Graft Failure, Donor Site Complication, Rotator Cuff Tear
- Keywords
- Arthroscopic Superior Capsular Reconstruction, Fascia Lata, Autograft, Donor Site Morbidity, Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Clara Isabel de Campos AzevedoUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.);
- Bilateral shoulder strength (supraspinatus, infraspinatus, subscapularis and teres minor) measured in kilograms with the use of a digital dynamometer;
- 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).
- 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.
- 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:
- 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.
- Identify any discontinuity of the onlay repair of the rotator cuff remnants, which, if present, will be classified a tear of the onlay repair.
- Grade the supraspinatus, infraspinatus, teres minor and subscapularis muscle fatty degeneration according to the Goutallier et al. classification.
- Grade the RCT tendon remnants retraction in the coronal plane according to the Patte classification.
- Grade the supraspinatus muscle atrophy according to the Thomazeau et al. classification.
- 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 AHI≥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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FL-ASCR | Experimental | Diagnostic Test: Magnetic Resonance Imaging of the shoulderMagnetic Resonance Imaging of the shoulder Radiograph of the shoulder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- FL-ASCR by the same surgeon (principal investigator) since 2015
- completed the preoperative and the 6 months postoperative clinical, radiological and MRI assessments
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging of the shoulderAlso: Shoulder radiograph, Range of motion and strength measurementsClinical and radiological assessments of the shoulders and the donor sites | Diagnostic test | FL-ASCR |
Primary outcome
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.
2 secondary outcomes
Autograft mid-term survivorship at 3 years postoperative
Time frame: 2 years
Fascia lata minimally invasive harvesting donor site morbidity impact at 3 years postoperative
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 30505873de Campos Azevedo CI, Angelo 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.
- Background: PubMed 30069653Angelo 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.
- Derived from this study: PubMed 32667265Azevedo CIC, Catarina Leiria Pires Gago Angelo A, Campos-Correia D, Delgado L, Ferreira N, Sevivas N. Clinical Importance of Graft Integrity in Arthroscopic Superior Capsular Reconstruction Using a Minimally Invasively Harvested Midthigh Fascia Lata Autograft: 3-Year Clinical and Magnetic Resonance Imaging Outcomes. Am J Sports Med. 2020 Jul;48(9):2115-2128. doi: 10.1177/0363546520928649.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara IC Azevedo, MD principal investigator
Centro Hospitalar de Lisboa Ocidental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging of the shoulder in people with Graft Failure and Donor Site Complication, run by Clara Isabel de Campos Azevedo at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder outcomes of FL-ASCR with minimally invasive harvesting at 3 years postoperative (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663036, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.