Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
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| First Received Date ICMJE | July 28, 2011 | ||||||||
| Last Updated Date | July 29, 2011 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Patient-reported improvement in symptoms at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01406821 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Reduction in patellar tendinosis by MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma | ||||||||
| Official Title ICMJE | Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis | ||||||||
| Brief Summary | Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. |
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| Detailed Description | Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire. Patients will be randomized and blinded to the treatment regimen. Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol. To blind the control group these patients will have a simulated needle stick and 10 ml (2 teaspoons) of blood will be drawn to test for growth factors. No blood will be given back to the patient. For those in the control group their ligament or tendon will be injected with saline. The staff nurse will place the blood (experimental group) or saline (control group) in syringes and the treating physician and patient will be blinded to the treatment. Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function. Post injection activity: All patients will be non-weight bearing for 24-48 hours after injection. All patients will have physical therapy two times a week according to a standardized protocol. Follow up at the clinic for all patients will be every other week from week 1-12. All patients will fill out an injury location specific questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain. All radiographic studies will be read by one Stanford radiologist blinded to the study groups. The endpoint for all patients in the study will be twelve weeks. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Tendinopathy | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: -Acute or chronic ligament or tendon injuries Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01406821 | ||||||||
| Other Study ID Numbers ICMJE | SU-10162010-7109, 16595 | ||||||||
| Has Data Monitoring Committee | |||||||||
| Responsible Party | Dr. Jason L. Dragoo, Stanford University School of Medicine | ||||||||
| Study Sponsor ICMJE | Stanford University | ||||||||
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| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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