Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201510001305535 Date of Approval: 13/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the safety and initial performance of the REPAIR Bone Putty in the treatment of patients with tibia fractures
Official scientific title A Randomized Controlled Clinical Study to Determine the Safety and Effectiveness of the REPAIR Bone Putty in Tibia Fractures
Brief summary describing the background and objectives of the trial Carmell Therapeutics has developed a bone void filler biomaterial (bone putty) that may be used as an adjunct to mechanical fixation and osteosynthesis plates in open tibial shaft fractures to accelerate and improve healing, reduce complications, and decrease hospital stays. The primary objective of this study is to evaluate the safety and initial product performance of the REPAIR Bone Putty in open tibia fracture repair. Safety and performance of the product will compared to clinical experience and data found in peer reviewed literature for current standard of care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Open tibia fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2012
Actual trial start date 12/07/2012
Anticipated date of last follow up 31/05/2014
Actual Last follow-up date 24/05/2014
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-1011-3790 NHREC
20120332 Medicines Control Council
RBP-SA-01 Carmell Therapeutics Corporation
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Adaptive randomization with age as a blocking factor Computer generated randomization Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group REPAIR Bone Putty 3 cc administered to fracture during time of reduction and stabilization Given during surgery Putty was placed directly at fracture site 20 Active-Treatment of Control Group
Control Group Standard of care NA At surgical reduction and wound closure Surgical debridement, fracture reduction and stabilization, wound repair 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients between the age of 18-75 inclusive; Patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and radiograms indicated for open fracture reduction and mechanical fixation; Definitive Wound Closure (DWC) within 14 days of initial injury; In bilateral open tibia fractures, only one fracture meeting all inclusion/exclusion criteria will be treated ¿ should both fractures meet the criteria, the selected fracture will be randomly chosen; ¿ Subject is willing to be available for post operative follow-up examinations; Willingness and ability to understand, participate and comply with the study requirements; Able to give consent personally and to sign the Consent Form; Females of non-childbearing potential or who have a negative pregnancy test with 72 hours. Type IIIc open fracture according to the Gustilo-Anderson classification; Tibial defects requiring bone grafting (e.g., large segmental defects); Duration from trauma to surgery longer than 14 days; Concomitant acute bone injuries and/or major skin or other injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process; Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years; Subject is participating in another investigational trial that has not completed the primary study endpoint phase; Taking medication known to potentially interfere with bone/soft tissue healing (e.g., long term use of corticosteroids but not intended to exclude inhalation medication for asthma); Active infection at the operative site or a systemic infection; Any psychosocial disorders that could impact the follow up assessments or informed consent process. 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2011 South African Medical Association
Ethics Committee Address
Street address City Postal code Country
Nossob Street Pretoria 0400 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/01/2012 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fracture healing 14, 30, 60, 90, 180, 365 days
Secondary Outcome Wound assessment 14, 30, 60, 90, 180, 365 days
Secondary Outcome Swelling 14, 30 60, 90, 180, 365 days
Secondary Outcome Tenderness 14, 30 60, 90, 180, 365 days
Secondary Outcome Neurovascular status 14, 30 60, 90, 180, 365 days
Secondary Outcome Infection 14, 30 60, 90, 180, 365 days
Secondary Outcome Weight Bearing 30, 60, 90, 180, 365 days
Primary Outcome Safety hospital discharge, 14, 30, 60, 90, 180, 365 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life Orthopaedic Hospital Alexandra Road Pinelands South Africa
Groote Schuur Hospital Anzio Road Observatory South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Carmell Therapeutics Corp. 3636 Boulevard of the Allies Pittsburgh 15213 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor 3 Degree Clinical Research & Consulting Office 6, Howard Center, Forest Drive Pinelands 7504 South Africa Commercial Sector/Industry
Primary Sponsor Carmell Therapeutics Corp. 3636 Boulevard of the Allies Pittsburgh 15213 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Brian Bernstein, MD Alexandra Road Pinelands South Africa
Sithombo Maqungo, MD Main Road Obersvatory South Africa
Marc Nortje, MD Alexandra Road Pinelands South Africa
David North, MD Main Road Observatory South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brian Bernstein bb@otg.org.za 021 506 5555 Alexandra Road
City Postal code Country Position/Affiliation
Pinelands South Africa Life Orthopaedic Hospital
Role Name Email Phone Street address
Public Enquiries Hein Botha hein@3degreegroup.com 021 531 7805 Forest Drive
City Postal code Country Position/Affiliation
Pinelands South Africa 3 Degree Clinical Research & Consulting
Role Name Email Phone Street address
Scientific Enquiries Alan West awest@carmellrx.com 4125086519 3636 Boulevard of the Allies
City Postal code Country Position/Affiliation
Pittsburgh 15213 United States of America Carmell Therapeutics Corp.
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information