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

A Registry for Those with Hypophosphatasia (HPP)

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

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

The Ohio State Lupus, Vasculitis and Glomerulonephritis Registry

Official Title

The Ohio State Lupus, Vasculitis and Glomerulonephritis Registry

Purpose

The purpose of the OSU Lupus and Vasculitis Registry is to obtain clinical and laboratory information about lupus and vasculitis and glomerulonephritis.

Could this study be right for you?

Patients at the Ohio State University Rheumatology and Lupus Clinic with one of the following diagnoses who are ages 18 years of age and older:
- Systemic lupus erythematosus
- Discoid lupus
- Mixed connective tissue disorder
- Undifferentiated connective tissue disorder
- Wegener’s granulomatosus
- Microscopic polyangiitis
- Henoch-Schonlien Purpura
- Takayasu’s arteritis
- Giant cell/temporal arteritis
- Churg-Strauss vasculitis
- Other vasculitides
- IgA nephropathy
- Anti-GBM GN
- Membranous GN
- Minimal Change Disease
- Focal Segmental Glomerulosclerosis

Age Range

18 and up