A Study for Those With Hip Impingement

Official Title
Physical Activity and Pain Patterns in Individuals with Femoroacetabular Impingement Syndrome
Purpose

Femoroacetabular impingement syndrome (FAIS), also known as hip impingement, is the most common reason for hip pain in young, active adults. It often causes pain with simple daily tasks like walking and squatting, but most often limits sports and physical activity participation. It is possible that way in which people move may increase their risk for FAIS. It is also possible that different activity patterns cause continued pain in those with FAIS. In order to develop effective rehabilitation programs, we need to figure out if there are patterns of activity (or inactivity) that contribute to pain in individuals with FAIS.

Could this study be right for you?

Inclusion Criteria:
Individuals ages 18-40 years with documentation of medical diagnosis of FAIS, with or without labral pathology and who meet the following criteria:
1. Complaints of hip joint pain, catching, or stiffness with prolonged sitting or standing, walking, squatting, pivoting/twisting, AND
2. Pain reproduced with at least one of three provocative tests: (1) hip flexion with adduction and internal rotation (FADIR), or (2) hip flexion with abduction and external rotation (FABER), or (3) resisted straight leg raise.

Exclusion Criteria:
Any of the following conditions or surgical history:
1. Previous history of hip surgery, including previous arthroscopy or open procedure on hip, including periacetabular osteotomy (PAO)
2. Medical diagnosis of slipped capital femoral epiphysis, hip dysplasia, Legg-Calve-Perthes disease, osteonecrosis, or fracture
3. History of hip dislocation
4. Medical diagnosis of bilateral FAIS AND is unable to identify a more symptomatic side
5. History of other lower extremity or spine injury or surgery that required continued care of a medical provider in the previous two years (conditions may have altered activity participation beyond that of the participant’s current hip pain)

Age Range
18 and up

A treatment study for chondral lesion in your knee

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:
o Medial femoral condyle
o Lateral femoral condyle
o Trochlea
o 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

A Study About Recovery After ACL Reconstruction (RARE)

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

A Treatment Study for Damaged Knee Cartilage Requiring Repair-- Hyalofast with BMAC

Official Title
A prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist reviewer and physician evaluator) multicenter study to establish the superiority of a hyaluronan-based scaffold (Hyalofast®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions in comparison to control (microfracture treatment)
Purpose

The purpose of this research study is to evaluate an investigational procedure for treatment of damage to the cartilage in your knee, also called a defect or lesion, which requires repair. If eligible, you will receive one of two possible arthoscophy procedures. You may be assigned to receive the study procedure to implant Hyalofast® scaffold in your knee together with cells from your own bone marrow, called Bone Marrow Aspirate Concentrate, or BMAC. Bone marrow is the substance found inside your bones that among other things helps to make blood cells. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition.

Could this study be right for you?

-Ages 18 to 60.
-Patient’s body mass index (BMI) is <35 kg/m2
-Patient has a symptomatic lesion of the femoral condyle (medial and/or lateral) or femoral trochlea that is between 1--6 cm2 on screening images confirmed by the independent radiologist
-Patient is using only nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol during the month before signing the informed consent form to treat knee pain
-Patient is willing to use other pain medication rather than NSAIDS for 6 months post-surgery (e.g. acetaminophen, or narcotic analgesics, if prescribed). Post-surgical use of aspirin for clot prevention is acceptable.
-Patient is willing to restrict pain medication after 6 months post-surgery to NSAIDs or acetaminophen/paracetamol only through the end of the trial
-No history of previous microfracture or other cartilage repair procedure on study knee
-Not currently pregnant or expecting to become pregnant in the next 12 months
-No diagnosis of advanced osteoarthritis

Age Range
18 and up

Follow-up Study for Those Who Have Undergone (or Will Undergo) the Subchondroplasty (SCP) Knee Procedure

Official Title
KNEE CREATIONS SCP® OBSERVATIONAL COHORT FOLLOW-UP STUDY
Purpose

A study for those who will (have undergone) the Subchondroplasty (SCP) procedure for their knee. SCP is a procedure performed on subjects who have bone marrow lesions(BMLs). BMLs are subchondral defects in the bone, also called Insufficiency Fractures. This follow-up study will collect information on the short- and long-term safety and effectiveness of the SCP procedure.

Could this study be right for you?

- 18 years of age or older
- Considered to be a candidate for SCP procedure by your surgeon
- Have agreed to undergo the SCP procedure or has already undergone the procedure
- Willing and able to sign a written consent form
- Has the ability and the willingness to contribute follow-up outcome data

Age Range
18 and up

Registry for Shoulder Surgery Outcomes

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

Rotator Cuff Study--For Those Who Require Surgical Treatment for Full Thickness Massive Tear

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

A Treatment Study for Single Articular Cartilage Lesion of the Knee--NOVOCART®3D (N3D)

Official Title
A Phase 3 Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART® 3D, Compared to Microfracture in the Treatment of Articular Cartilage Defects
Purpose

The purpose of this research study is to evaluate an investigational procedure for treatment of knee cartilage defects. If eligible, you will receive one of two possible surgical procedures. One is the investigational procedure under study, utilizes the Novocart® 3D autologous cartilage implant system. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.

Could this study be right for you?

Inclusion Criteria:
--Ages 18-65
•Little response to conservative treatment (non-operative treatments such as physical therapy, weight loss)
•Single articular cartilage lesion on the femoral condyle (round projection at the end of the femur) 2-6 cm2
•BMI less than 40

Exclusion Criteria:
•Instability of the knee joint
•Arthritis
•Autoimmune disease
•Immune suppression
•Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
•Bone disease
•Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Age Range
18 and up

The Effects of Dry Needling on Knee Pain

Official Title
The Effects of Dry Needling on Patients with Knee Pain
Purpose

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

Could this study be right for you?

Eligibility Criteria:
--Ages 18-40
--Referred for physical therapy
--Presence of knee pain (for at least 3 months) around the knee cap (patella) during ascending/descending stairs, squatting, and/or running.

Age Range
18 and up

Ankle Function Study for Healthy Volunteers OR Those with Ankle Instability or Nerve Damage

Official Title
Assessing Reliability and Validity of an iPod App for Measuring Ankle Proprioception
Purpose

We will assess ankle function by measuring how well you detect ankle movement using an iPod app. This information will help us to determine the validity of using an iPod app as a clinical tool for measuring ankle function and perception of rotation

The results of this study may inform us if the iPod app is an appropriate tool to use in the clinical setting as a more cost-effective, faster, and accessible tool when compared to the larger, more expensive Biodex machine.

Could this study be right for you?

Three groups (ages 18-80) are eligible for this study:

--Group 1--Those who are 60-80 years old, without history of ankle instability or nerve damage to lower extremities.

--Group 2--Those who are 18-60 years old and have a history of chronic ankle instability, recurrent ankle sprains. Have had at least 3 ankle sprains in the previous two (2) years, but none within 2 months of joining the study

--Group 3--Those who are 18-60 years old and have been diagnosed with peripheral neuropathy that has been induced by chemotherapy. Further screening will be done by the study team.

Age Range
18 and up