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Search Results within category "Sports Medicine"

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2 Study Matches

Platelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)

The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
Kenneth Lee, M.D.
All
18 Years to 39 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03136965
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Inclusion Criteria:
1. Age between 18 and 39 years 2. Chronic (>3 months) PT 3. Clinical examination consistent with PT 4. MRI or US confirmation of PT 5. Pain score of 3 or greater on a 10-point visual analogue scale 6. Self-report failure of supervised physical therapy 7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).
Exclusion Criteria:
1. Inability to comply with study follow-up requirements 2. History of bleeding disorders or other hematologic conditions 3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction) 4. Full or partial patellar tendon tear 5. Current use of anticoagulation or immunosuppressive therapy 6. Prior knee trauma requiring medical attention or surgery 7. Worker's compensation injury 8. Daily opioid use for pain 9. Contraindication to MRI. 10. Systemic diseases such as Diabetes and connective tissue diseases. 11. Prior PRP or DN procedure. 12. Women that are pregnant
Patellar Tendinitis, Musculoskeletal Abnormalities [C05], Patellar tendinitis, unspecified knee, Patellar tendinitis, right knee, Patellar tendinitis, left knee, Bone, Muscle & Joint, Pain & Pain Management
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Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella

The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee.
Brian Walczak
All
18 Years to 60 Years old
IV
This study is NOT accepting healthy volunteers
NCT03873545
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Inclusion Criteria:

• Patient is ≥18 and ≤ 60 years old at the time of surgery;
• Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e. medication, bracing, physical therapy) and/or previous surgical intervention;
• Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect on the femoral condyle or patella between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width;
• Will be having a marrow stimulation plus ProChondrix CR procedure;
• Has an intact meniscus (maximum of ≤50% resected);
• Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
Exclusion Criteria:

• Has > 5° of varus or valgus deformity;
• Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e. > than ICRS Grade 2 on the opposing articular surface);
• Associated damage to the underlying subchondral bone >2 mm requiring osseous repair;
• Requires concomitant ligament repair other than Anterior Cruciate Ligament (ACL) or Medial Patella-Femoral Ligament (MPFL) reconstruction;
• Body Mass Index (BMI)of ≥ 35 kg/m2;
• Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Clinical and/or radiographic disease in the affected joint that includes: osteoarthritis or avascular necrosis, gout or a history of gout or pseudogout, osteochondritis dissecans with significant bone loss;
• Cartilage lesion location such that the implanted graft will not be adequately shouldered;
• Active local microbial infection or a systemic infection, including prior or pending treatment for HIV, syphilis, Hepatitis B or Hepatitis C;
• Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation, chemotherapy or immunosuppression;
• Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes;
• Has a history of any inflammatory or connective tissue disease, such as, systemic lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis, polychondritis or rheumatoid arthritis;
• Received hyaluronic acid injections into the joint space ≤ 90 days prior to surgery;
• Is a female patient who is pregnant;
• Physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study;
• Has a history of substance abuse (recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program;
• Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
• Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days;
• Has any contraindications for MRI;
• Is a ward of the state, prisoner, or transient.
Cartilage Injury, Cartilage Damage, Sports Medicine
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