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UNC School of Medicine Orthopaedics, Orthopaedic Specialist, Chapel Hill, North Carolina | Clinical Research | Current Research

Current Studies

SHOULDER & ELBOW

  • Total Shoulder Replacement

    • Total Shoulder Arthroplasty Multi-Center Registry
      • You may be a candidate for this study if you have had an Arthrex anatomic or reverse total shoulder replacement.
      • This observational study collects information about patient experiences following shoulder replacement surgery.
        • Inclusion Criteria:
          • 18-100 years of age
          • Planned primary or revision anatomic or reverse total shoulder implant manufactured by Arthrex
          • Standard of care CT scan within 6 months of the study
        • Exclusion Criteria:
          • Any known intention, obligation, or co-morbidity that would inhibit participation in the study.
        • Study Measurements: Patient surveys, in-office range of motion evaluation, standard of care imaging.
        • Duration of Study: ongoing
        • Principal Investigator: Alex Creighton, MD
        • Study Coordinator: Kelsey Casadonte

  • Calcific Tendinitis

    • Prospective Multi-Center Patient Registry for Patients with Elbow, Hip, and Calcific Shoulder Tendinosis Treated utilizing the TenJet Hydroresection System
      • You may be a candidate for this study if you have had at least 3 months of pain from shoulder or elbow tendinitis with calcium deposits noted on ultrasound or MRI that has not improved with conservative treatment.
      • This observational study records the outcomes of the use of Tenjet in the treatment of calcific tendinitis. Tenjet is a water jet technology that is already approved by the FDA and used in clinical practice to remove abnormal scar tissue without damaging normal tendon tissue.
        • Inclusion criteria:
          • 18-70 years of age
          • At least 3 months of symptoms and conservative treatment for tendon pain.
          • Physical examination and imaging with ultrasound or MRI which is consistent with the diagnosis of calcific tendinitis
        • Exclusion Criteria:
          • Full thickness tendon tear
          • Unable to hold anticoagulant (blood thinning) medication for 7 days prior to procedure
          • Use of more than 81 mg of aspirin daily or a non-steroidal anti-inflammatory medication within 7 days of the procedure
          • Steroid, PRP, stem cell, or biologic injection within 3 months of the procedure
          • Needle tenotomy, Tenex, or surgical treatment within 6 months of the procedure.
          • Active systemic infection requiring treatment
          • Chronic medical condition which could affect pain levels.
        • Study Measurements: Patient surveys including pain scales.
        • Duration of Study: up to 24 months
        • Principal Investigator: David Berkoff MD
        • Study Coordinator: Kelsey Casadonte

  • Shoulder Instability

    • Surgical Treatment of Shoulder Instability with Bone Loss (OASIS)
      • You may be a candidate for this study if you have a history of shoulder dislocation and have been told that you have bone loss on the socket side of the joint.
      • This is an interventional study in which patients are randomly selected to have one of the three common surgeries used to treat this condition (arthroscopic bankart repair with remplissage, open Bankart repair, or Laterjet) with outcomes recorded for comparison
        • Inclusion Criteria:
          • 17-50 years of age
          • Traumatic shoulder dislocation with an associated 10-20% glenoid (socket-sided) bone loss.
        • Exclusion Criteria:
          • Non-traumatic or multidirectional instability
          • Other shoulder tissue injury such as rotator cuff tear, vascular or nerve injury, or arthritis.
          • Prior rotator cuff repair or instability surgery other than isolated arthroscopic Bankart repair
          • Significant humeral head bone loss (large Hill Sachs)
          • Cartilage injury that would affect outcome.
        • Study Measurements: Patient surveys, clinical range of motion, strength, and functional assessment.
        • Duration of Study: 24 months
        • Principal Investigator: Alex Creighton, MD
        • Study Coordinator: Kelsey Casadonte

Wrist & Hand

Spine

Total Joint Replacement

HIP

  • Calcific Tendinitis

    • Tenjet Study for Calcific Tendinitis of the Elbow, Hip, or Shoulder
      • You may be a candidate for this study if you have had at least 3 months of pain from hip tendinitis with calcium deposits noted on ultrasound or MRI that has not improved with conservative treatment.
      • This observational study records the outcomes of the use of Tenjet in the treatment of calcific tendinitis. Tenjet is a water jet technology that is already approved by the FDA and used in clinical practice to remove abnormal scar tissue without damaging normal tendon tissue.
        • Inclusion criteria:
          • 18-70 years of age
          • At least 3 months of symptoms and conservative treatment for tendon pain.
          • Physical examination and imaging with ultrasound or MRI which is consistent with the diagnosis of calcific tendinitis
        • Exclusion Criteria:
          • Full thickness tendon tear
          • Unable to hold anticoagulant (blood thinning) medication for 7 days prior to procedure
          • Use of more than 81 mg of aspirin daily or a non-steroidal anti-inflammatory medication within 7 days of the procedure
          • Steroid, PRP, stem cell, or biologic injection within 3 months of the procedure
          • Needle tenotomy, Tenex, or surgical treatment within 6 months of the procedure.
          • Active systemic infection requiring treatment
          • Chronic medical condition which could affect pain levels.
        • Study Measurements: Patient surveys including pain scales.
        • Duration of Study: up to 24 months
        • Principal Investigator: David Berkoff MD
        • Study Coordinator: Kelsey Casadonte

KNEE

  • Anterior Cruciate Ligament (ACL) Injuries

    • Lower Extremity Assessment Protocol (LEAP)
      • You may be a candidate for this study if you have had a recent ACL reconstruction.
      • This study evaluates the improvement in lower leg strength and function following ACL reconstruction surgery and post-operative physical therapy. Evaluations are performed by strength and jump testing.
        • Inclusion Criteria:
          • 12-64 years of age
          • History of knee injury resulting in an ACL tear requiring surgical treatment.
        • Exclusion Criteria
          • Pregnancy
        • Study Measurements: Patient surveys, balance and strength testing, jump landing, and walking evaluation.
        • Duration of Study: One year following surgery but with option to return for yearly repeat evaluation for up to 10 years
        • Principal Investigator: Joseph Hart III PhD ATC
        • Study coordinators: Devin Kelly PhD and Gabrielle DelBiondo
  • Clinically Assessed Risk Factors for a Second ACL Injury Using an Innovative Wearable Sensor (ACL-CARE)
    • You may be a candidate for this study if you have had a prior ACL reconstruction.
    • This is an observational study in which patients with ACL reconstructions wear a flexible load-sensing shoe insert which records force during jumping tasks.
      • Inclusion Criteria:
        • 13-25 years of age
        • Have had a primary ACL reconstruction using an autograft
        • Have been cleared by the treating orthopaedic surgeon to return to full sport participation
      • Exclusion Criteria:
        • Skeletal immaturity (open growth plates)
        • Have had more than one ACL reconstruction
        • Had a tibial osteotomy at the time of the ACL surgery
        • Had an allograft (cadaver graft)
        • Had any post-operative complications that required repeat surgery
        • Have been hospitalized for any reason other than the ACL injury in the past 3 months.
        • Have no plans to be physically active after sports clearance
      • Study Measurements: Patient surveys, knee examination, tests of strength, walking, running, and jumping tasks while wearing study shoe insert.
      • Duration of Study: 18 months
      • Principal Investigator: Joseph Hart III PhD ATC
      • Study Coordinator: Gabrielle DelBiondo

  • Knee Osteoarthritis

    • KneeBRIGHT Focus Groups: Physical Therapists and Patient Perspectives
      • You might be a candidate for this study if you are between the ages of 35 and 75 years and have been diagnosed with knee osteoarthritis or are a physical therapist who treats such patients.
      • This study will involve recording the experiences and opinions of patients and physical therapists as they are introduced to the KneeBright device which is a video game-based concept for providing feedback in real time as patients perform leg strengthening exercises.
        • Study Criteria:
          • Patient age 35-75 years or physical therapist who is 18+ years old who treats knee osteoarthritis
          • Have been diagnosed with osteoarthritis in one or both knees
          • Can walk distance of 100 feet without assistive device.
        • Exclusion Criteria:
          • Pain > 6/10 on a pain scale
          • Inability to walk 100 feet without assistive device
          • Neurologic condition that affects balance.
        • Study Measurement: Patient surveys
        • Duration of Study: one time assessment
        • Principal Investigator: Joseph Hart III PhD ATC
        • Study Coordinator: Gabrielle DelBiondo
    • A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis (SKOAP)
      • You might be a candidate for this study if you have been diagnosed with knee osteoarthritis.
      • This study evaluates the response of patients randomized to different treatment groups to monitor improvement in symptoms. In phase I patients will be randomized to treatments involving combinations of anti-inflammatory medications, additional non-opioid medications, and cognitive behavior therapy programs. In Phase II, additional more invasive treatments such as knee joint injections, nerve blocks, and nerve ablation may be added.
        • Inclusion Criteria:
          • Adults over the age of 18 with the diagnosis of knee osteoarthritis that causes pain.
        • Exclusion Criteria:
          • < 18 years of age
          • No significant pain from the arthritis or other conditions which cause pain
          • Changes in pain medication management in the past 2 weeks or treatment with oral morphine of >90 mg per day.
          • History or scheduled knee replacement surgery
          • Active joint infection
          • Knee injection or arthroscopic surgery within 12 weeks
          • Open wound(s) around the knee
        • Study Duration: 4 years
        • Principal Investigator: David Berkoff MD
        • Study Coordinator: Kelsey Casadonte

Foot & Ankle

Trauma

PEDIATRIC ORTHOPAEDICS

  • Fractures

    • Cast or Operation for Medial Epicondyle Fracture in Children (COMET)
      • You may be a candidate for this study if you are a child between the ages of 7-17 years with a recent history of medical epicondyle fracture of the elbow.
      • This study is a randomized trial that evaluates the outcomes of treating medical epicondyle fracture either with a surgery (open reduction and internal fixation) or with immobilization in a cast without reduction.
        • Inclusion Criteria:
          • 7-17 years of age
          • History of acute (injury within 10 days) fracture of the medial epicondyle of the elbow with any amount of displacement.
          • Able to take oral medications and adhere to immobilization.
        • Exclusion Criteria
          • Medial epicondyle fragment within the joint
          • Presence of other fractures of the same elbow
          • Pathologic or open fracture
          • Metabolic or neuromuscular disease that can impact healing.
        • Study Measurements: Patient surveys, x-rays
        • Duration of Study: One year
        • Principal Investigator: ***
      • Study coordinator: Malvika Choudhari
    • Distal Radius Interventions for Fracture Treatment (DRIFT)
      • You may be a candidate for this study if you are a child between the ages of 4-10 years with a recent history of displaced distal radius fracture.
      • This study is a randomized trial that evaluates the outcomes of treating distal radius fractures with either immobilizing in a cast without reduction or with closed reduction under conscious sedation followed by casting.
        • Inclusion Criteria:
          • 4-10 years of age
          • History of acute (injury within 10 days) 100% dorsally displaced fracture of the distal radius.
          • Fracture at least 5 cm from the distal radial growth plate
          • Able to adhere to immobilization.
        • Exclusion Criteria
          • Fracture involvement of the growth plate.
          • Pathologic or open fracture
          • Metabolic or neuromuscular disease that can impact healing.
          • Fracture that is > 10 days old
        • Study Measurements: Patient surveys, x-rays
        • Duration of Study: 36 months
        • Principal Investigator: ***
      • Study coordinator: Malvika Choudhari
    • Simple Bone Cysts in Kids (SbOCK)
      • You may be a candidate for this study if you are between the ages of 2-21 years with a diagnosis of a simple bone cyst in the arm or leg.
      • This randomized study evaluates the effects of two treatments (curettage and puncture alone or curettage and puncture followed by injection of a bone substitute) in improving the pain and reducing the re-fracture rate of patients with simple bone cysts.
        • Inclusion Criteria:
          • 2-21 years of age
          • Confirmed simple bone cyst in the arm or leg within the last 3 months
          • At least 3 weeks since last fracture
          • At least 3 months since last cyst treatment
          • Stabilizing implants in the bone where the cyst is located
        • Exclusion Criteria
          • Pregnant or breastfeeding
          • Bone disease
          • Patients with cysts that cross the growth plate
        • Study Measurements: Patient surveys, x-rays
        • Duration of Study: 2 years
        • Principal Investigator: ***
        • Study coordinator: Malvika Choudhari