Rotator Cuff TearNCT03739749
Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts
A study testing Arthroscopic superior capsular reconstruction in people with Rotator Cuff Tear and Graft Complication, run by Hospital de Egas Moniz at 1 site in Portugal.
Trial summary
Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different… Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Rotator Cuff Tear, Graft Complication
- What is being tested?
- Arthroscopic superior capsular reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Oct 2018to 30 Oct 2022
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator cuff tear arthropathy, Hamada stage 1 or 2
- Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging
Who cannot join
- Rotator cuff tear arthropathy, Hamada stage 3 or 4
- Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
- Proximal humerus fracture
- Acute shoulder dislocation (in the previous 8 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts
Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.
Read the detailed description
Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft.
All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P<0.05.
- Conditions
- Rotator Cuff Tear, Graft Complication
- Being tested
- Arthroscopic superior capsular reconstruction
- Keywords
- Arthroscopic Superior Capsular Reconstruction, Irreparable rotator cuff tear, Allograft, Autograft, Xenograft
- 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.
Arthroscopic superior capsular reconstructionProcedure or surgery
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
| Study group | Role | What they receive |
|---|---|---|
| Fascia lata autograft | Active comparator | Arthroscopic superior capsular reconstruction using a fascia lata autograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
| Fascia lata allograft | Active comparator | Arthroscopic superior capsular reconstruction using a fascia lata allograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
| Achilles tendon allograft | Active comparator | Arthroscopic superior capsular reconstruction using an achilles tendon allograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
| Bovine pericardium allograft | Active comparator | Arthroscopic superior capsular reconstruction using a bovine pericardium allograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
| Swine dermal xenograft | Active comparator | Arthroscopic superior capsular reconstruction using a swine dermal xenograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
| Collagen allograft | Active comparator | Arthroscopic superior capsular reconstruction using a collagen allograft Receives: Procedure: Arthroscopic superior capsular reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
Constant score at 2 years postoperatively (minimum 1 point - maximum 100 points); For the scale range provided, higher values represent a better outcome
Measured: 2 years
Secondary outcomes (5)
Graft integrity on the magnetic resonance imaging
Graft integrity on the 2-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
Shoulder active range of motion
Shoulder active range of motion (ROM) at 2 years postoperatively measured in degrees using an analogic goniometer: elevation (0 - 180º), abduction (0 - 180º) and external rotation (0 - 100º); 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. For the scale range provided, higher values represent a better outcome.
Measured: 2 years
Simple shoulder test
Simple shoulder test ((minimum 1 point - maximum 12 points) at 2 years postoperatively. For the scale range provided, higher values represent a better outcome.
Measured: 2 years
Acromiohumeral interval
True anteroposterior shoulder radiograph at 2 years postoperatively: 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. For the scale range provided, higher values represent a better outcome.
Measured: 2 years
Shoulder strength
Shoulder strength at 2 years postoperatively measured in kilograms using a digital dynamometer: supraspinatus (0 - 25 kg).For the 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 posted14 Nov 2018
- Study start30 Oct 2018
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Why it stopped: Multicenter failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multiple group assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Egas Moniz
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, General Hospital of Santo António, Centro Hospitalar De São João, E.P.E., Hospital Santa Maria Maior de Barcelos, CUF Santarém Hospital, Hospital de Braga, Unidade Local de Saúde de Coimbra, EPE, Hospital Cuf Descobertas, Hospital Vila Franca de Xira
- Responsible party
- Principal investigator, Clara Isabel de Campos Azevedo, Hospital de Egas Moniz
- Investigators
- Clara Azevedo, Principal investigator, Centro Hospitalar de Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739749
- Sponsor's protocol ID
- 01-2018-10HSFX
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lippitt S, Harryman DT, Matsen F. A pratical tool for function evaluation: the
Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
PubMed 2323151Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
PubMed 18061114
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts
- ClinicalTrials.gov ID
- NCT03739749
- Acronym / sponsor ID
- 01-2018-10HSFX
- Conditions
- Rotator Cuff Tear, Graft Complication
- Keywords
- Arthroscopic Superior Capsular Reconstruction, Irreparable rotator cuff tear, Allograft, Autograft, Xenograft
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Multicenter failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital de Egas MonizUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, General Hospital of Santo António, Centro Hospitalar De São João, E.P.E., Hospital Santa Maria Maior de Barcelos, CUF Santarém Hospital, Hospital de Braga, Unidade Local de Saúde de Coimbra, EPE, Hospital Cuf Descobertas, Hospital Vila Franca de Xira
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 14 Nov 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.
Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.
Detailed description
Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft.
All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Multiple group assignment
| Arm | Type | Receives |
|---|---|---|
| Fascia lata autograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using a fascia lata autograft |
| Fascia lata allograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using a fascia lata allograft |
| Achilles tendon allograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using an achilles tendon allograft |
| Bovine pericardium allograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using a bovine pericardium allograft |
| Swine dermal xenograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using a swine dermal xenograft |
| Collagen allograft | Active comparator | Procedure: Arthroscopic superior capsular reconstructionArthroscopic superior capsular reconstruction using a collagen allograft |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rotator cuff tear arthropathy, Hamada stage 1 or 2
- Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging
Key exclusion criteria (4 listed)
- Rotator cuff tear arthropathy, Hamada stage 3 or 4
- Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
- Proximal humerus fracture
- Acute shoulder dislocation (in the previous 8 weeks)
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 |
|---|---|---|
| Arthroscopic superior capsular reconstructionThe superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft | Procedure or surgery | Achilles tendon allograft, Bovine pericardium allograft, Collagen allograft, Fascia lata allograft, Fascia lata autograft, Swine dermal xenograft |
Primary outcome
Constant score
Time frame: 2 years
Constant score at 2 years postoperatively (minimum 1 point - maximum 100 points); For the scale range provided, higher values represent a better outcome
5 secondary outcomes
Graft integrity on the magnetic resonance imaging
Time frame: 2 years
Shoulder active range of motion
Time frame: 2 years
Simple shoulder test
Time frame: 2 years
Acromiohumeral interval
Time frame: 2 years
Shoulder strength
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- BackgroundLippitt S, Harryman DT, Matsen F. A pratical tool for function evaluation: the
- Background: PubMed 2323151Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
- Background: PubMed 3791738Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
- Background: PubMed 18061114Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
- 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 Azevedo 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 Arthroscopic superior capsular reconstruction in people with Rotator Cuff Tear and Graft Complication, run by Hospital de Egas Moniz 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 4 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: withdrawn, as of the sponsor's last update on 28 Feb 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Constant score (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 NCT03739749, which also lists 4 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 28 Feb 2023.