Official Title Project Limb Rescue: A pilot study evaluating the feasibility of transcutaneous sensors for the detection of cancer-related lymphedema

Purpose

The goal of this study is to use new, adhesive-based sensors (pads that stick on your skin) to detect lymphedema, and to develop a way for patients to check for lymphedema at home.

This study will assist in distinguishing participants with lymphedema in comparison to participants without lymphedema at rest by using a combination of photoplethysmography (PPG) and bioimpedance (BI). Photoplethysmography is an optical technique that can be used to detect blood volume changes in tissue. Bioimpedance evaluates how tissue responds to an externally applied electrical current.

Could this study be right for you?

• History of cancer-related lymphedema, cancer in your arm, or the lymph nodes in the arm
• History of cancer therapy with surgery or radiation involving the axillary basin and upper arm that requires compression or pneumatic therapy
• Physically capable of performing a brief bike riding exercise for about seven minutes
• No metal implants
• Willingness to take off shoes and any metal jewelry
• Not currently pregnant
• Not currently incarcerated

Age Range

18 - 90 years

Official Title BUckeye Concussion Knowledge Survey (BUCKS)

Purpose

The purpose of this study is to examine health outcomes in former Ohio State University athletes who played a varsity sport during their time at OSU. The objective is to determine whether athletes who sustained a concussion have different health outcomes than those who did not sustain a concussion. Any former OSU varsity athlete can participate in a 20-minute online survey.

Could this study be right for you?

• Anyone who has played a varsity sport as an undergraduate student at OSU, and they have now graduated (i.e., OSU athlete alumni). There are no other restrictions in terms of age, sex/gender, type of sport, etc.

Age Range

18 years and up

Official Title Effects of Knee Brace Stiffness on Muscle Control following Total Knee Replacement

Purpose

The purpose of this study is to determine the effects of various knee braces on how you walk.

Participation in this study consists of 1 session lasting 2-3 hours. During testing, you will walk on a treadmill during several trials, each lasting 2-5 minutes. While walking, you will wear a knee brace, motion capture markers, and muscle activation sensors.

Could this study be right for you?

Knee Replacement participants:

• Men and women aged 45-89 years old
• Can walk for 45 minutes without stopping
• Received a TKR (total knee replacement) in the last 2 years

Healthy participants:

• Men and women aged 45-89 years old
• Can walk for 45 minutes without stopping
• No history of lower limb surgery

Exclusion criteria:

• Lower extremity surgeries (other than knee replacement)
• Spine pain
• Scoliosis
• Known pregnancy

Exclusion criteria varies, please contact Study Coordinator for more information.

Age Range

45 and up

Official Title SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Purpose

To determine whether placement of iFuse-3D across the ssacroiliac joint (SIJ) in the Bedrock configuration provides
clinical and/or radiographic benefits in patients undergoing multilevel spine fusion (MLF) surgery with fixation to the pelvis

Could this study be right for you?

You may be eligible for this study if you are:

1. Age 21-75 at time of screening
2. Scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria

1. The reason for your multilevel spine fusion surgery is any of the following:
   • Congenital neuromuscular disease
   • Prior pelvic fixation (already have S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
   • Grade IV spondylolisthesis
2. Prior sacroiliac joint fusion/fixation on either side
3. Presence of spinal cord stimulator
4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
5. Surgeon plans to use iliac screw for pelvic fixation
6. Severe osteoporosis
7. Known allergy to titanium or titanium alloys
8. Current local or systemic infection that raises the risk of surgery
9. Currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SIJ or low back pain.
10. Currently pregnant or planning pregnancy in the next 2 years
11. Known or suspected drug or alcohol abuse
12. Fibromyalgia

Age Range

21 and up

Official Title Evaluation of the efficacy of radiofrequency-based debridement vs. mechanical debridement for the treatment of articular cartilage lesions.

Purpose

The purpose of this study is to evaluate 2 different treatments, Mechanical Debridement (i.e., a mechanical shaver that removes areas of damaged tissue) and Radiofrequency Debridement (i.e., electrical energy that removes areas of damaged tissue), used to treat the chondral lesion in your knee.

Could this study be right for you?

You may be eligible for this study if you:

• Are 18 - 50 years of age
• Suspected chondral damage in the following locations where debridement is indicated:
  • Medial femoral condyle
  • Lateral femoral condyle
  • Trochlea
  • Patella
• 1 or more chondral lesion(s) as noted on MRI

Exclusion:

• Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable)
• Pregnant and/or intending to become pregnant during this study period

Age Range

18 and up

Official Title Disability after ACL Reconstruction: Development of an Alternative Model of Care

Purpose

The anterior cruciate ligament (ACL) in your knee can be injured and treated with an ACL reconstruction surgery. An ACL reconstruction may impact function, muscle strength, the way you move, and knee joint health. However, outcomes at 2 years after ACL reconstructions in young persons are not well-understood. Findings from this study will provide information regarding the clinical, function, muscle strength, and movement patterns after ACL injury and reconstruction to help inform physicians and physical therapists who work with these patients.

Could this study be right for you?

You may be eligible if:

1. You are between the ages of 16-35 years old
2. 2 years (+/- 8 months) status post ACL Reconstruction
3. Regularly participated in physical activity prior to their ACL injury

Age Range

16 and up

Official Title The Spine Phenome Project

Purpose

This study is designed to capture information about your spine. We will collect information from wearable sensors while you move your low back and neck. We will also collect a series of questionnaires and information from your medical record that related to your spine health. We want to compare the health history and motion capabilities of participants with healthy spines to participants with back and neck pain disorders. We believe that capturing and analyzing this information together will advance our understanding of low back and neck disorders and help develop healthcare applications, tools, or devices that improve the way we prevent, evaluate, and treat spine disorders. You will complete up to 8 visits and participate in the study for up to 5 years.

Could this study be right for you?

To participate, you must meet the following criteria:

• Age 18-80
• Able to speak, read, and understand English
• Able to stand for 20 minutes

Please let us know if you have any of the following as you may not be eligible to participate (not a complete list):

• Currently pregnant
• Currently seeing or planning to see a medical provider for low back or neck pain
• History of chronic low back or neck pain lasting longer than 3 months
• Severe back or spine curvature (example – scoliosis)
• Current condition requiring a back brace
• History of spine surgery
• History of brain or spine cancer
• Open wounds on back or neck
• Current spine infection

Age Range

18 and up

Official Title Shoulder Surgery Outcomes Registry

Purpose

This registry will collect outcomes data of patients undergoing shoulder surgery with Dr. Jonathan Barlow or Dr. Julie Bishop. The purpose of this registry is to provide a way to collect and store data for patients undergoing shoulder surgery to support the conduct of future research in an effort to improve patient outcomes.

Could this study be right for you?

• A patient undergoing surgery with Dr Jonathan Barlow or Dr Julie Bishop (will be asked to enroll once the clinical decision has been made to proceed with surgery)
• 18 to 89 years old
• Able to provide consent

Age Range

18 and up

Official Title A prospective, single blinded, multi-center, randomized, controlled, pivotal study to assess the safety and effectiveness of the InSpace™ device for treatment of full thickness Massive Rotator Cuff Tears

Purpose

This research study will evaluate a new device, InSpace, for use with a full thickness massive tear of rotator cuff (the group of connective tissues in the shoulder). The device is designed to allow smooth gliding of the bones in the shoulder during motion, which may allow rehabilitation exercises with less pain. The research study is being conducted to see whether the InSpace device is safe and effective for shoulder problems due to a full thickness massive rotator cuff tear.

Could this study be right for you?

1. Is male or female ≥ forty (40) years of age
2. Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: measuring ≥ 5 cm in diameter (Cofield classification) and involving ≥ two tendons
3. Functional deltoid muscle and preserved passive range of motion on physical examination
4. Failed non-operative treatment of at least 4 months from the initial treatment to include one or all of the following: Oral analgesics, Anti-inflammatory medication (e.g., ibuprofen, naproxen), Corticosteroid injection(s), Physical therapy, Activity modification, or Rest (sling used)
5. Must be able to read and understand the approved Informed Consent Form (written and oral)
6. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
7. Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.

Other details will be shared by the study coordinator.

Age Range

40 and up

Official Title AN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIA

Purpose

The purpose of this registry is to collect information about Hypophosphatasia (HPP), a rare bone disorder characterized by the abnormal development of bones and teeth. This long-term registry will collect and store patient medical information, and other related information to use in medical research. the registry may help researchers better understand the condition and learn more about patients who have HPP. This data may help other people with HPP in the future.

Could this study be right for you?

• 18 years of age or older
• Been diagnosed with Hypophosphatasia (HPP) - a rare genetic disorder characterized by the abnormal development of bones and teeth.
• Not participating in another Alexion-sponsored clinical trial

Age Range

18 and up