Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274378
Status:
COMPLETED
Last Update Posted:
2009-07-30
First Post:
2006-01-06
Brief Title:
Allomatrix Injectable Putty in Distal Radius Fractures
Sponsor:
Université Catholique de Louvain
Organization:
Université Catholique de Louvain
Study Overview
Official Title:
Allomatrix Injectable Putty in Distal Radius Fractures Protocol for a Randomised Controlled Clinical Study in Unstable Fractures of the Distal Radius
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium sulfate hemihydrate and carboxymethylcellulose Allomatrix combines the osteoinductive capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium sulfate
Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position
There is a parallel between the quality of the anatomic result and the residual capacity of the wrist except in older low demanding patients
Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragmentsMoreover a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties However the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up
Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position
There is a parallel between the quality of the anatomic result and the residual capacity of the wrist except in older low demanding patients
Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragmentsMoreover a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties However the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up
Detailed Description:
STUDY DESIGN
The study is designed as a randomised prospective study with concurrent control A total of 50 patients will be enrolled by one centre and will be randomised into two groups One group of patients comprising 50 of the study population will have ALLOMATRIX Injectable Putty implanted In a control group of patients comprising 50 of the study population as well no graft material will be used
Patients will be randomly assigned to one of the two treatment arms Sequentially numbered randomisation envelopes will be provided Once the surgical reduction and stabilisation has been completed the next sequentially numbered randomisation envelope will be opened and the patient will receive the treatment listed within the envelope Each envelope will contain one of the treatment arms based on a computer generated randomised schedule
DURATION AND ENDPOINTS OF THE STUDY The enrollment period is expected to be about 3 years Patients will be followed from a pre-operative visit through a one-year visit
Study End Points
Comparison of time to healing of the fracture
Comparison of function of operated wrist
Radiographic and densitometric assessment of bone regeneration
Failure rates Non-union malunion fracture instability wrist stiffness
Complication rates infection drainage hardware failure wound dehiscence
Bone growth factors on blood samples from both forearms at 3 weeks after surgery
PATIENT SELECTION
The study is directed to unstable distal radius fractures among types I III and V according to the classification of Fernandez 4
It was decided to follow a group of younger patients because the outcome in older low demand patients is not significantly dependent of a precise reduction contrary to the outcome in younger high demand patients 15
STUDY PRACTICAL INFORMATION
1 For each patient presenting as a candidate for the study the inclusion and exclusion criteria should be reviewed After informed consent pre-operative data are collected see case report form and regular pre-operative data are collected to plan the operation The patient is usually operated within one week after the injury with distal radius fracture
2 The treatment protocol of distal radius fractures relies on a decision scheme developped by Fernandez and Wolfe 21 We favored percutaneous stabilisation over open reduction and internal fixation No significant clinical difference was noted between those two techniques in unstable fractures 22 The surgical procedure is conducted under brachial plexus anesthesiaFor type I and III 4 the fracture is reduced manually with image intensifier control One or two Kirshner wires 15mm are directed from the tip of the radial styloid dorsally to the first extensor compartment at an angle of approximately 45 degrees to cross the fracture and enter the dorsoulnar cortex of the radius proximally to the fracture These wires are placed using a power drill An additional wire is placed into the fracture fragment inserted into the dorsoulnar corner of the radius between the fourth and fifth extensor compartments and directed from dorsoulnarly towards palmar radially in a distal to proximal direction6 The tips of the wires are bent and left just outside the skin if necessary resorbable sutures Vicryl 30 are used For type III fractures 4 an external fixator bridging the joint completes usually the procedure The criteria for reduction3 are an ulnar inclination of 22 a palmar inclination of 11 neutral ulnar variance and radial width distance from the most lateral tip of the radial styloid process to the longitudinal axis through the center of the radius on an AP film A radioscopic image of the contralateral wrist is taken in the operating room to serve as control in the same prosupination conditions to be standardized in the radiology department1920 The angles are measured preoperatively with an appropriate software OEC radioscopy and controlled postoperatively with the same radioscopy software
At the end of the surgical reduction and stabilization of the fracture the sequentially numbered randomization envelope will be opened and the patient will receive the treatment listed within the envelope either the ALLOMATRIX Injectable Putty or no additional graft
The study is designed as a randomised prospective study with concurrent control A total of 50 patients will be enrolled by one centre and will be randomised into two groups One group of patients comprising 50 of the study population will have ALLOMATRIX Injectable Putty implanted In a control group of patients comprising 50 of the study population as well no graft material will be used
Patients will be randomly assigned to one of the two treatment arms Sequentially numbered randomisation envelopes will be provided Once the surgical reduction and stabilisation has been completed the next sequentially numbered randomisation envelope will be opened and the patient will receive the treatment listed within the envelope Each envelope will contain one of the treatment arms based on a computer generated randomised schedule
DURATION AND ENDPOINTS OF THE STUDY The enrollment period is expected to be about 3 years Patients will be followed from a pre-operative visit through a one-year visit
Study End Points
Comparison of time to healing of the fracture
Comparison of function of operated wrist
Radiographic and densitometric assessment of bone regeneration
Failure rates Non-union malunion fracture instability wrist stiffness
Complication rates infection drainage hardware failure wound dehiscence
Bone growth factors on blood samples from both forearms at 3 weeks after surgery
PATIENT SELECTION
The study is directed to unstable distal radius fractures among types I III and V according to the classification of Fernandez 4
It was decided to follow a group of younger patients because the outcome in older low demand patients is not significantly dependent of a precise reduction contrary to the outcome in younger high demand patients 15
STUDY PRACTICAL INFORMATION
1 For each patient presenting as a candidate for the study the inclusion and exclusion criteria should be reviewed After informed consent pre-operative data are collected see case report form and regular pre-operative data are collected to plan the operation The patient is usually operated within one week after the injury with distal radius fracture
2 The treatment protocol of distal radius fractures relies on a decision scheme developped by Fernandez and Wolfe 21 We favored percutaneous stabilisation over open reduction and internal fixation No significant clinical difference was noted between those two techniques in unstable fractures 22 The surgical procedure is conducted under brachial plexus anesthesiaFor type I and III 4 the fracture is reduced manually with image intensifier control One or two Kirshner wires 15mm are directed from the tip of the radial styloid dorsally to the first extensor compartment at an angle of approximately 45 degrees to cross the fracture and enter the dorsoulnar cortex of the radius proximally to the fracture These wires are placed using a power drill An additional wire is placed into the fracture fragment inserted into the dorsoulnar corner of the radius between the fourth and fifth extensor compartments and directed from dorsoulnarly towards palmar radially in a distal to proximal direction6 The tips of the wires are bent and left just outside the skin if necessary resorbable sutures Vicryl 30 are used For type III fractures 4 an external fixator bridging the joint completes usually the procedure The criteria for reduction3 are an ulnar inclination of 22 a palmar inclination of 11 neutral ulnar variance and radial width distance from the most lateral tip of the radial styloid process to the longitudinal axis through the center of the radius on an AP film A radioscopic image of the contralateral wrist is taken in the operating room to serve as control in the same prosupination conditions to be standardized in the radiology department1920 The angles are measured preoperatively with an appropriate software OEC radioscopy and controlled postoperatively with the same radioscopy software
At the end of the surgical reduction and stabilization of the fracture the sequentially numbered randomization envelope will be opened and the patient will receive the treatment listed within the envelope either the ALLOMATRIX Injectable Putty or no additional graft
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None