Use of Graft Jacket for Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product
      used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright
      Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human
      dermis. The primary purpose of this study is to determine whether rotator cuff repair
      augmentation using GraftJacket allograft provides a viable alternative, based on observed
      clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The
      study will secondarily investigate the difference in outcomes in patients treated
      arthroscopically versus open. This study will report patient progress and results at early (6
      month) and late (2 year) time points in patients treated for large and massive reparable
      rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it
      is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus
      without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and
      re-tear rate will be included in the study evaluations.
    

Detailed description: 
      This is a prospective multi-center clinical study evaluating GraftJacket in the augmentation
      of large and massive rotator cuff tears compared to the traditional surgical technique of
      sutures and anchors alone. The study group will consist of 160 patients (early withdrawals or
      drop outs will not be replaced). Surgical approach for each patient will be either mini-open
      or arthroscopic. Safety assessments for this clinical study will be based on reported adverse
      events. Any adverse event that occurs during the study that represents a change from the
      patient's condition as noted at baseline [determined by normal standard of care] that is
      related to the procedure will be documented by completing the adverse events case report
      form.

      Each investigator will indicate which operative technique (mini-open or arthroscopic) will be
      used during the study period at their site. The site selection process will be used to
      attempt to attain an equal distribution of both operative techniques used in the study.
      Patients will be randomly assigned to the treatment groups A or B. A randomization scheme
      using a 2 block model will be used within each surgical technique. Randomization cards
      meeting the requirements for this process will be generated by the statistician. Both
      surgical technique treatment groups will use the same assessments for comparisons throughout
      the study period.

      Enrollment Plan for the GraftJacket Rotator Cuff Tendon Reinforcement Scaffold Surgical
      Technique Open Surgical (suture and anchor) Arthroscopic Group A without augmentation Group B
      with GraftJacket Group A without augmentation Group B with GraftJacket

      Patients with reparable rotator cuff repairs must present with large and massive rotator cuff
      tears of more than 3cm, which can be repaired either arthroscopically or by open surgery to
      be eligible for enrollment. A reparable rotator cuff tear is defined as a tear of the rotator
      cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity
      of the humerus without excessive tension. It should be possible to accomplish a watertight
      repair or only leave a residual defect of less than or equal to 1cm. The anteroposterior and
      mediolateral dimensions of the rotator cuff tear will be assessed intra-operatively by
      measurements either including the edges or after the edges are trimmed depending on the
      judgment of the surgeon. Rotator cuff tears involving the subscapularis tendon will not be
      included in the study, because the postoperative rehabilitation is more difficult and may
      confound the outcome results of either group. Surgical variables that should be documented on
      source documents and appropriate CRFs are the size of rotator cuff tear, the number of
      tendons involved, the type of repair (open, mini-open, arthroscopic) and the type and number
      of sutures and anchors.

      Both clinical assessments and magnetic resonance imaging will be used to evaluate the
      effectiveness of the surgical techniques in both groups A and B. A screen/baseline MRI will
      be obtained of the affected shoulder during the preoperative visit. This MRI will be used to
      evaluate the extent of involvement and determine suitability for enrollment into the study
      including the size of the tear and extent of muscle atrophy. Images obtained within 3 months
      of signing consent may be used to assess eligibility for enrollment. Three additional
      follow-up MRIs of the affected shoulder will be obtained as part of the 2 year post-operative
      evaluation and will be used to evaluate structural success of group A, suture and anchor or
      group B, GraftJacket® allograft augmentation. The MRI scans performed at 6 months, 12 months
      and 24 months will be used to determine the rate of re-tear and to help to assess the
      integrity of the rotator cuff. Re-tears which are evident on the 6-month MRI will be
      considered a failure of the surgical technique, will be excluded from further follow-up
      within the study and followed separately. The comparison of the proportions of re-tears in
      patients in groups A and B who complete the MRI regimen through 2 years will be used to
      determine if GraftJacket® augmentation is a viable alternative to suture and anchor.

      The Investigator will use clinical, functional, radiological, assessment of adverse events
      and assessment of the surgical techniques of groups A or B to evaluate each patient enrolled
      in this clinical study.

      Pre Operative Procedures - Screen (Baseline)

      Screening activities are performed during Visit 1. The protocol requires the following
      assessments during that visit:

        -  Informed consent process completed before any study related activities begin

        -  Inclusion/Exclusion criteria evaluation for study entry qualifications

        -  Magnetic Resonance Imaging (MRI)

        -  American Shoulder and Elbow Society (ASES) Scale

        -  University California Los Angeles (UCLA) Score

        -  Constant-Murley Score (CMS) Operative Procedures

      The protocol requires completion of the following assessments during Visit 2:

        -  Open wound evaluation of rotator cuff tear for classification as large or massive with
           measurement of the tear to confirm size and length

        -  Enrollment confirmed using WMT randomization scheme for patient assignments Post
           Operative Procedures

      Protocol requires the following assessments to be completed during the 1 month (plus 15 days)
      -Visit 3; 3 month (plus 15 days)-Visit 4; 6 month (plus 30 days) -Visit 5 and 12 month (plus
      30 days) -Visit 6:

        -  MRI - Only performed during the 6 month (plus 30 day)-Visit 5 and 12 month (plus 30
           days) -Visit 6

        -  ASES Scale

        -  CMS

        -  UCLA Score End of Study

      Protocol requires completion of the following assessments during 24 month (plus 30
      days)-Visit 7:

        -  MRI

        -  ASES Scale

        -  CMS

        -  UCLA Score

        -  Completion of End of Study Evaluation Form by the Principal Investigator

      4.7 Scientific validity of the study design: Address the strengths and weaknesses of the
      selected design. Specifically indicate why a particular design was selected.

      (1 page maximum - adhere to page limitations) Strengths: Prospective Randomized Clinical
      Trial Weakness: While not a true weakness, this trial is not randomized in the regular way
      but is using the "Expertise Randomization" style where the surgeon chooses his particular
      expertise of surgical repair of the rotator cuff (mini-open or arthroscopic) and the patients
      are randomized within that group.

      A telephone randomization scheme cannot be used so there will be envelopes available to the
      surgeon in the OR for the group.
    

Intervention name(s): Augmentation; Rotator Cuff Repair without augmentation
Intervention type(s): Device; Procedure
Intervention description(s): Rotator Cuff Repair plus Graft Jacket; Rotator Cuff Repair without augmentation
Other intervention name(s): Wright Medical Technology Graft Jacket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rotator cuff; randomized clinical trial