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Trial record 49 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

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ClinicalTrials.gov Identifier: NCT03739749
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 15, 2018
Sponsor:
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
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Hospital Cuf Descobertas
Hospital Vila Franca de Xira
Information provided by (Responsible Party):
Clara Isabel de Campos Azevedo, Hospital de Egas Moniz

Brief 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 type of graft is used.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Graft Complication Procedure: Arthroscopic superior capsular reconstruction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fascia lata autograft
Arthroscopic superior capsular reconstruction using a fascia lata autograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Active Comparator: Fascia lata allograft
Arthroscopic superior capsular reconstruction using a fascia lata allograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Active Comparator: Achilles tendon allograft
Arthroscopic superior capsular reconstruction using an achilles tendon allograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Active Comparator: Bovine pericardium allograft
Arthroscopic superior capsular reconstruction using a bovine pericardium allograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Active Comparator: Swine dermal xenograft
Arthroscopic superior capsular reconstruction using a swine dermal xenograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Active Comparator: Collagen allograft
Arthroscopic superior capsular reconstruction using a collagen allograft
Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Graft integrity on the magnetic resonance imaging [ Time Frame: 2 years ]
    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.

  2. Shoulder active range of motion [ Time Frame: 2 years ]
    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.

  3. Simple shoulder test [ Time Frame: 2 years ]
    Simple shoulder test ((minimum 1 point - maximum 12 points) at 2 years postoperatively. For the scale range provided, higher values represent a better outcome.

  4. Acromiohumeral interval [ Time Frame: 2 years ]
    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.

  5. Shoulder strength [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739749


Contacts
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Contact: Clara Azevedo +351938453848 claracamposazevedo@gmail.com

Locations
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Portugal
Centro Hospitalar de Lisboa Ocidental Recruiting
Lisboa, Portugal, 1700-348
Contact: Clara Azevedo, MD    00351938453848    claracamposazevedo@gmail.com   
Contact: Clara Azevedo    00351938453848    claracamposazevedo@gmail.com   
Sponsors and Collaborators
Hospital de Egas Moniz
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
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Hospital Cuf Descobertas
Hospital Vila Franca de Xira
Investigators
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Principal Investigator: Clara Azevedo Centro Hospitalar de Lisboa Ocidental

Publications:
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Responsible Party: Clara Isabel de Campos Azevedo, Principal Investigator, Hospital de Egas Moniz
ClinicalTrials.gov Identifier: NCT03739749     History of Changes
Other Study ID Numbers: 01-2018-10HSFX
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clara Isabel de Campos Azevedo, Hospital de Egas Moniz:
Arthroscopic Superior Capsular Reconstruction
Irreparable rotator cuff tear
Allograft
Autograft
Xenograft

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries