Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 10:57 AM
Study NCT ID:
NCT01000935
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intevention involved PRP injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-10-22', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Pain Scale', 'timeFrame': 'The primary outcome will be collected pre and post-operatively. The level of pain and medication utilization will be monitored throughout the study by completing a pain diary (day 1-30) and at 6 weeks, 3 months and 6 months following surgery.'}], 'secondaryOutcomes': [{'measure': 'Adverse Effect', 'timeFrame': '6 months'}, {'measure': 'Magnetic resonance Imaging (MRI)', 'timeFrame': '6 months after surgery', 'description': 'The main secondary evaluation tool is the healing index examined by the post-operative MRI. In order to assess tendon healing, anatomic evaluation of the cuff repair will be done with use of a MRI as the investigation of choice. A postoperative MRI will be performed at a minimum of six months following surgery. The images will be reviewed by a senior radiologist who is blinded to patient group allocation.'}, {'measure': 'Patient- focused outcomes', 'timeFrame': 'Before surgery and 3 and 6 months following surgery', 'description': '1. The SHORT Western Ontario Rotator Cuff Index\n2. The American Shoulder and Elbow Surgeons (ASES) form\n3. The Constant- Murley Score (CM) outcome measure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Decompression Repair'], 'conditions': ['Rotator Cuff Pathology']}, 'referencesModule': {'references': [{'pmid': '27660800', 'type': 'BACKGROUND', 'citation': 'Holtby R, Christakis M, Maman E, MacDermid JC, Dwyer T, Athwal GS, Faber K, Theodoropoulos J, Woodhouse LJ, Razmjou H. Impact of Platelet-Rich Plasma on Arthroscopic Repair of Small- to Medium-Sized Rotator Cuff Tears: A Randomized Controlled Trial. Orthop J Sports Med. 2016 Sep 13;4(9):2325967116665595. doi: 10.1177/2325967116665595. eCollection 2016 Sep.'}], 'seeAlsoLinks': [{'url': 'http://journals.sagepub.com/doi/abs/10.1177/2325967116665595', 'label': 'Online access'}]}, 'descriptionModule': {'briefSummary': 'Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions that often require surgical treatment. Initial efforts to improve tendon healing centered on improving the strength of the repair construct. More recent studies have focused on biologic enhancement of the healing process. The use of platelet concentrates to improve healing, has been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.\n\nThere is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon, and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that have examined the impact of PRP in patients with rotator cuff tear.\n\nThe objective of the proposed pilot study is to examine the effectiveness of autologous Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons following arthroscopic rotator cuff repair through a randomized controlled study.', 'detailedDescription': 'Surgical procedures: Arthroscopic inspection of the shoulder will be performed to assess intra-articular structures and to evaluate the rotator cuff and other sub-acromial structures.\n\nArthroscopic Rotator Cuff Repair: Rotator cuff tears will be categorized as partial-thickness and full-thickness tears. The full-thickness tears will be classified as small (\\<1 cm), moderate (1-3 cm), and large (\\>3-5 cm) based on the largest dimension and will be treated with a repair using sutures and suture anchors as indicated.\n\nRehabilitation: A comprehensive protocol with instructions on different types of exercises will be provided pre-operatively. Rehabilitation will be based on the standard protocols for these procedures used at the Holland Centre.\n\nFollow-ups: Patients will be monitored for 6 months, or when participation is terminated by the investigators, or because the patient withdrew consent or fails to return for visits. To evaluate safety, clinical laboratory (WBC, Hb, platelet count, serum chemistry and IL-6, CRP, PT, PTT and INR tests will be conducted at 6 weeks, and 3 months to determine the impact of treatment interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age \\>18 years\n2. Diagnosis of partial or full-thickness rotator cuff tear of less or equal to 3 cm. confirmed by MRI or US within a period of 6 months prior to booking surgery.\n3. The final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology.\n\nExclusion Criteria\n\n1. Unable to speak or read English\n2. Non-repairable tear\n3. Acute tears (\\<6 month)\n4. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder\n5. Concurrent pathology of Superior Labral Anterior and Posterior (SLAP) lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint\n6. Previous surgery of the affected shoulder\n7. Bone marrow pathology\n8. Abnormal platelet count\n9. Serum hemoglobin concentration \\<11 g/dL or hematocrit \\<34%\n10. Use of systemic cortisone\n11. Current use of anticoagulants (i.e. Aspirin)\n12. Use of an investigational drug and/or blood donation within the previous 3 months prior to surgery\n13. Substance or alcohol abuse\n14. Heavy smoking \\[a daily cigarettes consumption of more than 20 pieces, based on definition of the World Health Organization (WHO)\\]\n15. Psychiatric illness that precludes informed consent'}, 'identificationModule': {'nctId': 'NCT01000935', 'briefTitle': 'Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet Rich Plasma', 'description': "The platelet concentrate extracted from patient's own blood (PRP) will be applied to the surgical site after completion of the repair.", 'interventionNames': ['Other: Platelet Rich Plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Surgical repair (standard-of-care)', 'description': 'Patients will have a rotator cuff repair without the PRP application.'}], 'interventions': [{'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'description': "Patient's blood will be drawn prior to the start of the procedure. The processing disposable (PD) size of 60ml will be used to yield 7 ml of Platelet concentrate volume. Using the lateral portal, the applicator for the PRP will be positioned in between the bone and the repaired rotator cuff without a cannula. The inflow will then be closed and the arthroscopic fluid will be aspirated via the outflow cannula. All other cannulae will be removed, producing a dry subacromial space. The PRP and autologous thrombin will then be transferred to the sterile field and drawn up into a dedicated spray applicator kit (Smartjet) and applied to the site of repair. A dry arthroscopic check will be performed to evaluate the clot formation of the applied solution.", 'armGroupLabels': ['Platelet Rich Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4Y1H1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Richard Holtby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Dr. Helen Razmjou', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}