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Trial record 49 of 578 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

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Constant score [ Time Frame: 2 years ]
Constant score at 2 years postoperatively (CS, 1 - 100 points); For the scale range provided, higher values represent a better outcome
Change History Complete list of historical versions of study NCT03739749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • 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.
  • 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.
  • Simple shoulder test [ Time Frame: 2 years ]
    Simple shoulder test (SST, 1 - 12 points) at 2 years postoperatively. For the scale range provided, higher values represent a better outcome.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts
Official Title  ICMJE Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multiple group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rotator Cuff Tear
  • Graft Complication
Intervention  ICMJE Procedure: Arthroscopic superior capsular reconstruction
The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
Study Arms  ICMJE
  • Active Comparator: Fascia lata autograft
    Arthroscopic superior capsular reconstruction using a fascia lata autograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
  • Active Comparator: Fascia lata allograft
    Arthroscopic superior capsular reconstruction using a fascia lata allograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
  • Active Comparator: Achilles tendon allograft
    Arthroscopic superior capsular reconstruction using an achilles tendon allograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
  • Active Comparator: Bovine pericardium allograft
    Arthroscopic superior capsular reconstruction using a bovine pericardium allograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
  • Active Comparator: Swine dermal xenograft
    Arthroscopic superior capsular reconstruction using a swine dermal xenograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
  • Active Comparator: Collagen allograft
    Arthroscopic superior capsular reconstruction using a collagen allograft
    Intervention: Procedure: Arthroscopic superior capsular reconstruction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clara Azevedo +351938453848 claracamposazevedo@gmail.com
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03739749
Other Study ID Numbers  ICMJE 01-2018-10HSFX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clara Isabel de Campos Azevedo, Hospital de Egas Moniz
Study Sponsor  ICMJE Hospital de Egas Moniz
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Clara Azevedo Centro Hospitalar de Lisboa Ocidental
PRS Account Hospital de Egas Moniz
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP