Evaluation of the Healicoil Suture Anchor for Rotator Cuff Repair
Condition: Rotator Cuff Tear Repair Anchors
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the
      Smith & Nephew Healicoil anchor. This anchor utilizes a small open-construct design to
      promote bone-in growth and potentially allow for the release of bone marrow factors into the
      repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator
      cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth.

      Thus, this study consists of three separate aims in order to clinically and biochemically
      investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff repair.
      One, evaluate the bone in growth of the anchor compared to a standard poly-ether ether ketone
      (PEEK) anchor. Two, analyze the marrow elements that are released into the repair site
      through the open construct. Three, compare the functional outcomes of patients with rotator
      cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK anchor.
    

Detailed description: 
      A great deal of research has been devoted to determining optimal techniques for rotator cuff
      repair, a common orthopedic procedure. Current repair techniques involve the use of suture
      anchors or transosseous tunnels, with the goal of reattaching the torn tendon to the anatomic
      insertion of the rotator cuff. There are a multitude of different repair constructs and
      anchor designs available. For example, some surgeons utilize a single row of suture anchors
      for repair, whereas others will use two rows of anchors in a "double row" construct. A
      variety of anchors are also available; some are loaded with suture and require knot tying,
      and others can be used in a "knotless" technique. Regardless, time zero stability of the
      rotator cuff repair is essential, but ideal anchor or construct has yet to be determined.

      Time zero stability immediately after the rotator cuff repair is important, however,
      contemporary research has also focused on the cascade that influences biologic healing of
      these rotator cuff repairs and if augmentation can improve functional results. Specifically,
      various authors have looked at the cytokines, growth factors and stem cells involved in the
      process. The question remains of what role these factors play and whether there are
      techniques that can facilitate their use and improve healing of rotator cuff repairs. Data
      exists in a animal models that does show that some of these growth factors can improve tendon
      healing.

      Research Plan:

      The proposed study will be a prospective randomized trial of 40 patients undergoing
      arthroscopic repair of full thickness rotator cuff tears. Patients will be randomized to one
      of two groups; the Healicoil anchor vs standard 5.5 PEEK anchor. Follow-up will take place at
      6 weeks, 6 months, and 1 year after rotator cuff repair.

      At the time of the operative procedure bone marrow aspirate from the drill hole used for the
      anchors will be sent for analysis. At the 6 month mark patients will get a computer
      tomography (CT) scan in order to determine the amount of ingrowth within the anchor. Finally,
      the outcome scores within the first year will be recorded. This data will result in the
      publication of three separate studies.

        -  Growth factor and stem cell analysis at the time of the operative procedure

        -  CT ingrowth of the Healicoil anchor at 6 months

        -  Clinical outcomes of patients with rotator cuff repair using the Healicoil anchor

      Enrollment Process:

      Patients who are determined clinically to have a full thickness rotator cuff tear and who
      elect to have surgery will be invited to participate in this study. Informed consent will be
      obtained pre-operatively in the office setting. A physical examination of both shoulders will
      be conducted, and all patients will complete a shoulder survey in order to determine baseline
      values for the Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder
      Score (ASES), University California, Los Angeles activity score (UCLA), and Constant scores.

      Eligible patients will be randomized into one of two study groups at the time of surgery.
      Enrollment will continue until 20 patients are in each group. Participants in the control
      group will undergo rotator cuff repair utilizing 5.5mm full thread Twinfix PK anchors for
      tendon fixation. Those in the experimental group will undergo the same procedure, but with
      the use of Smith & Nephew Healicoil anchors. Participants will be blinded as to the
      anchor-type received.

      Operative Procedure:

      A standard rotator cuff repair will be completed utilizing a medial row Healicoil and a
      lateral row PEEK anchor. At the time of drilling for the anchors, bone marrow aspirate will
      be collected by turning off the water and using a large gauge biopsy needle to aspirate the
      contents of the drill hole. The anchors will then be placed. The aspiration process is then
      repeated and a smaller gauge needle will be used to aspirate within the open construct of the
      Healicoil anchor. All material will be sent to the laboratory of Dr. Chubinskaya for
      immediate analysis of:

        -  IGF-1

        -  FGF-2

        -  BMP-7

        -  BMP-2

        -  PDGF-CHAIN A

        -  PDGF-CHAIN B

        -  EGF

        -  VEGF

        -  Mesenchymal stem cells

      Office Visits:

      Following surgical rotator cuff repair, all patients will return for routine post-operative
      follow-up at 6 weeks, 6 months, and one year. The 6 week visit will involve a clinical exam
      and assessment of shoulder range of motion.

      At the 6 month and 1 year visits, patients will complete the subjective and objective outcome
      measures and have a physical examination of both shoulders by a member of the research team.
      Subject participation will last approximately 30 minutes. Subjective and objective measures
      will include:

        -  Shoulder Survey - including SANE, VAS, ASES, Constant score

        -  Shoulder physical exam

      The shoulder Survey may be collected by paper or electronically using OBERD (Rush approved
      repository - ORA #12042506). The shoulder Survey data which was collected up to 30 days
      before the time of surgery will be sued as baseline data.

      CT Scanning:

      At the 6 month follow up visit patients will undergo a directed CT scan of the affected
      humeral head only. The scan will provide 1 mm cuts through the humeral head greater
      tuberosity (site of anchor) only. This will limit the amount of radiation exposure to the
      patient and will provide the necessary data. Previous authors have shown that this technique
      can make the radiation exposure to the patient roughly equivalent to a standard chest xray.

      These CT scans will be evaluated for the presence of bone within the confines of the anchor.
      One mm scanning will allow for quantitative volume analysis of the bone present.

      Planned Analysis:

      Descriptive statistics will be obtained for the age at time of surgery, physical examination
      findings, range of motion, standardized scores, bone marrow growth factor analysis, and bone
      in-growth as evaluated by CT scan. The statistical analysis will be conducted at a p level of
      < .05. Statistical tests that will be used to obtain inferential statistics of findings
      include paired t-tests and ANOVA.

      Geoffrey S. Van Thiel, MD, MBA and Scott W. Trenhaile, MD are collaborating investigators at
      Rockford Orthopedics in Rockford, Illinois, Rush will subcontract with Rockford Orthopedics
      to enroll subjects, treat per study protocol and do follow-up visits. The bone marrow
      analysis of Rockford subjects will be done here at Rush. Rockford Orthopedics will use their
      local IRB for the study.
    

Intervention name(s): Smith & Nephew Healicoil Anchor; Smith & Nephew Twinfix Anchor
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other