{
  "FullStudy":{
    "Rank":218260,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510639",
          "OrgStudyIdInfo":{
            "OrgStudyId":"R-08.05A/PDGF"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"NL19106.100.07",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"CCMO"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"St. Antonius Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery",
          "OfficialTitle":"Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery",
          "Acronym":"PRP"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"July 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 30, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 1, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Dr. N. Wolterbeek",
            "ResponsiblePartyInvestigatorTitle":"Study Coordinator",
            "ResponsiblePartyInvestigatorAffiliation":"St. Antonius Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"St. Antonius Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.",
          "DetailedDescription":"Subacromial surgery of the shoulder is performed often. It concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). In this kind of surgery good wound healing and tissue recovery is of great importance to achieve optimal results. Wound healing disorders, pain and the formation of adhesions may negatively influence the postoperative course and lead to extended rehabilitation. This has an unfavourable influence on the personal well being of the patient and the possibility to return to labour. Especially in cuff surgery the course is strongly influenced by the healing of the attachment of the cuff to the bone. Besides the development of minimal invasive techniques, it's necessary to look for possibilities to decrease the morbidity of these procedures. Recent studies show that growth factors play a major role in wound healing. This concerns particularly TFG-B (transforming growth factor B) and PDGF (platelet derived growth factor) present in thrombocytes. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both growth factors stimulate the wound healing and cause improved angiogenesis and fibroplasia. They also play a role in wound retraction and remodelling. In animal-experimental models it is proved that the application of TGF-B and PDGF improves woundhealing and leads to better mechanical properties of the scar tissue. Faster and better wound healing and decreased development of adhesions after subacromial surgery can possibly be influenced favourably by using thrombocyte concentrate. In the treatment with autologous thrombocyte concentrate a thrombocyte rich concentrate is obtained by a centrifuging method (Gravitational Platelet System (GPS), Biomet, Warsaw USA) (platelet rich plasma or PRP), that can be applied in the operating field. The concentrate is harvest from the patients own blood, sampled during the procedure. At random the concentrated is applicated and both groups are compared postoperatively."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Rotator Cuff Rupture",
              "Subacromial Impingement"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"73",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Cuff repair PRP",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Cuff repair Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the cuff repair group",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Platelet Rich Plasma"
                  ]
                }
              },{
                "ArmGroupLabel":"Cuff repair Control",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"No intervention"
              },{
                "ArmGroupLabel":"NEER PRP",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Neer Platelet Rich Plasma: The application of autologous thrombocyte concentrate in the NEER surgery group",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Platelet Rich Plasma"
                  ]
                }
              },{
                "ArmGroupLabel":"NEER Control",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"No intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"Platelet Rich Plasma",
                "InterventionDescription":"The application of autologous thrombocyte concentrate (PRP). This is a concentrate with a high amount of thrombocytes (containing growth factors), obtained by centrifuging the patient's own blood. The concentrate is applied into the subacromial space after closure.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cuff repair PRP",
                    "NEER PRP"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in VAS pain",
                "PrimaryOutcomeDescription":"Change in painscore measured on a VAS scale",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Functional recovery",
                "SecondaryOutcomeDescription":"Several questionnaires (RAND-36, SST, and Constant score) and functional tests are measured (Range of motion)",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"The amount of patients that had adequate wound healing",
                "SecondaryOutcomeDescription":"At different follow-up moments would healing is evaluated (6 weeks - 12 weeks - 1 year - 2 years)",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"The amount of patient who were able to resume their work",
                "SecondaryOutcomeDescription":"At different follow-up moments it is evaluated if patients was able to resume work (6 weeks - 12 weeks - 1 year - 2 years)",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge >18 years old\nGiven informed consent\nClinical indication for Arthroscopic Sub-acromial decompression, i.e.: Painful arc, pain at abduction, positive Hawkinstest Insufficient clinical improvement after (at least) 6 months of conservative treatment or Clinical indication for a arthroscopic cuff repair of a MRI-proven treatable rotator cuff tear.\n\nExclusion Criteria:\n\nCoagulopathy\nThrombocytopenia\nUse of corticosteroids\nDiabetics Mellitus\nOmarthritis\nAC-arthrosis\nCuff arthropathy\nNeurological deficit at the ipsi-lateral extremity\n(Wish for) Pregnancy\nVAS <2 or VAS >9",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Petra E Flikweert, drs",
                "OverallOfficialAffiliation":"St Antoniusziekenhuis",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Gie Auw yang, Dr",
                "OverallOfficialAffiliation":"St. Antoniusziekenhuis",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Jacco Zijl, drs",
                "OverallOfficialAffiliation":"St. Antoniusziekenhuis",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"st. Antoniusziekenhuis",
                "LocationCity":"Nieuwegein",
                "LocationZip":"3430 EM",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000019534",
                "ConditionMeshTerm":"Shoulder Impingement Syndrome"
              },{
                "ConditionMeshId":"D000012421",
                "ConditionMeshTerm":"Rupture"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              },{
                "ConditionAncestorId":"D000007592",
                "ConditionAncestorTerm":"Joint Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              },{
                "ConditionAncestorId":"D000070599",
                "ConditionAncestorTerm":"Shoulder Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13824",
                "ConditionBrowseLeafName":"Rupture",
                "ConditionBrowseLeafAsFound":"Rupture",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20060",
                "ConditionBrowseLeafName":"Shoulder Impingement Syndrome",
                "ConditionBrowseLeafAsFound":"Subacromial Impingement",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9204",
                "ConditionBrowseLeafName":"Joint Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M602",
                "ConditionBrowseLeafName":"Shoulder Injuries",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}