Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000052336
Ethics application status
Not yet submitted
Date submitted
21/01/2008
Date registered
29/01/2008
Date last updated
29/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to assess the use and effectiveness of GEMOS2 in achieving early bone formation and healing of distal radius fractures.
Scientific title
A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate GEM
OS2 (ß-TCP/collagen matrix combined with rhPDGF-BB) for the Treatment of Unstable Distal Radius Fractures
Universal Trial Number (UTN)
Trial acronym
BMTI-2006-04-AUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
distal radius fractures 2754 0
Condition category
Condition code
Musculoskeletal 2881 2881 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GEM OS2 is applied to the bone void(s) and is contained within the fracture void(s) it physically fills bone defects providing a biocompatible, osteoconductive scaffold for new bone formation and promoting
cellular ingrowth into the osseous defect.
This device is composed of two components: a beta
tricalcium phosphate (ß-TCP) / collagen matrix, and becaplermin, which is a highly purified recombinant human platelet-derived growth factor (rhPDGF-BB).-derived growth factor (rhPDGF-BB). The GEM OS2 device is supplied as a single use kit, with sterile individual components of ß-
TCP/collagen matrix and a separate syringe containing a solution of rhPDGF-BB (becaplermin).
At the time of surgery, the clinician fully saturates the ß-TCP/collagen matrix with the rhPDGF BB solution. After mixing, the hydrated graft will have a putty consistency which may be injected percutaneously, or manually packed into the osseous defect dependent on the method of fixation. As this device is surgically implanted it will remain and be taken up by the body as the fracture heals.

The GEM OS2 device is supplied as a two component kit. Each kit consists of: one (1) “brick” containing 3 cc of b-TCP/ collagen; and, one (1) syringe containing 3 mL solution of 0.3 mg/ml rhPDGF-BB (becaplermin) in sodium acetate buffer. When combined there is a total of 0.9 mg rhPDGF-BB in the 3 mL that may be implanted at the fracture site. It has been estimated that each patient will receive approximately 1mL at minimum and no more than 3 mL at maximum which equates to 0.3mg rhPDGF-BB at minimum and no more than 0.9mg rhPDGF-BB at maximum.
Intervention code [1] 2492 0
Treatment: Devices
Comparator / control treatment
All subjects will be treated by percutaneous reduction, minimally invasive or non-invasive fixation techniques, including casting, external fixation, external fixation with percutaneous pins. Only the patients randomised to the GEM OS2 group will receive the bone filler.
percutaneous pins or screws with cast or minimal fixation device
Control group
Active

Outcomes
Primary outcome [1] 3766 0
Radiographic assessment of time to fracture healing evaluated by an independent radiologist.
Timepoint [1] 3766 0
Within 2 weeks of fracture, Day 0, Day 7-14, Week 3, 4, 5, 6, 9 12 and 24.
Secondary outcome [1] 6315 0
Healing rate compared to control as assessed by radiographic outcomes evaluated by a qualified radiographer.
Timepoint [1] 6315 0
Within 2 weeks of fracture, Day 0, Day 7-14, Week 3, 4, 5, 6, 9 12 and 24.
Secondary outcome [2] 6316 0
Time to removal of external fixation device or cast as determined by clinical healing
assessment:
o Radiographic evidence of healing
o Pain upon fracture site palpation
Timepoint [2] 6316 0
Week 6, 9, 12 and 24
Secondary outcome [3] 6317 0
Grip strength will be assessed with three measures averaged using a Jamar
Dynamometer (Bechtol et al, 1954). The grip strength score will be the ratio of the grip strength of the injured side to that of the uninjured side.
Timepoint [3] 6317 0
These measurements will be made at all posttreatment after permanent removal of the cast. (Weeks 6, 9, 12 and 24)
Secondary outcome [4] 6318 0
Pain Subscale Score: will be evaluated using the Patient-Rated Wrist Evaluation: (PRWE) subscale score.
Timepoint [4] 6318 0
Screening, Day7-14 post op, Weeks 3, 4, 6, 9, 12 and 24
Secondary outcome [5] 6319 0
Function Subscale Score will be assessed by using the Patient-Rated Wrist Evaluation (PRWE)
Timepoint [5] 6319 0
Screening, Day7-14 post op, Weeks 3, 4, 6, 9, 12 and 24
Secondary outcome [6] 6320 0
Range of Motion: Measurement:
Movement of the wrist (flexion/extension, pronation/supination, radial/ulnar
deviation) will be measured using a goniometer.
Determinations of both active and passive range of motion will be made. Movement of the unaffected wrist will be taken as the normal range for each subject.
Timepoint [6] 6320 0
Weeks 6, 9, 12 and 24

Eligibility
Key inclusion criteria
Subjects who meet the following criteria may be included in the study if they present with all of
the following:
1) The subject has signed the Independent Ethics Committee (IEC) approved Informed
Consent Form specific to this study prior to enrollment
2) The subject has an unstable unilateral, extraarticular distal radius fracture classified as
unstable with the following radiographic findings: wide displacement requiring reduction
defined as >10° or 20° volar tilt or instability defined as 20° dorsal tilt; or an intraarticular
fracture that is amenable to external-fixation or closed fracture reduction.
Avulsed ulnar styloid tip is allowed
3) The subject’s fracture is able to be manually reduced in a single attempt up to 2 weeks
post injury
4) The subject is independent, ambulatory, and can comply with all post-treatment
evaluations and visits
5) The subject is skeletally mature and =18 years of age
6) The distal radius fracture does not require structural bone graft.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded from the study if they present with any of the following:
1) The subject has suffered a previous wrist fracture on the affected wrist or contralateral
wrist within the previous 12 months of the current fracture date
2) The subject’s fracture meets any of the following criteria:
• Bilateral distal radius fractures or clinically significant injury to the contralateral limb.
• Severe comminution involving the diaphysis of the radius and/or radioulnar joint.
• Ulnar fracture (AO: A1.1, A1.2, and A1.3)
• Presence of pre-operative hard or soft tissue infection at the operative site.
• Requires supplemental internal fixation for adequate reduction (e.g. plates)
• Open fractures
• Closed head injuries
• Intra-articular fracture with diastasis of the subchondral bone
3) The subject is currently undergoing radiotherapy or chemotherapy
4) The subject has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis (e.g., renal osteodystrophy)
5) The subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Note: NSAID use is excluded during the first 6 weeks post-treatment
6) The subject has a clotting disorder or uses anticoagulant therapy (e.g., coumadin). Antiplatelet therapy is acceptable for daily cardiovascular maintenance
7) The subject has a pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements
8) The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, etc.)
9) The subject has an allergy to yeast-derived products
10) Allergy to bovine collagen and/or to other bovine source medication, supplements or products
11) The subject is enrolled in another device or drug investigational study (currently or within the past 30 days of surgery or during the follow-up phase of this study)
12) The subject is a prisoner, is known or suspected to be transient, or has a history of drug/alcohol abuse (as determined by investigator) within the 12 months prior to screening for study entry
13) The subject is pregnant or a female intending to become pregnant during this study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment in the study begins at the time written consent is obtained. The Investigator is responsible for verifying that the subject meets all inclusion and has none of the exclusion criteria prior to randomisation of the subject. Each clinical site will be provided with a set of sealed randomisation envelopes containing the treatment assignment. The randomisation schedule will be determined electronically under the supervision of a statistician. The The subjects will be randomly assigned to one of the following groups in a 1:1 ratio: Group I: GEM OS2 or Group II: No bone graft material. Randomization assignments will not be re-used in the event that the subject withdraws from the study prior to treatment, or becomes an intra-operative treatment failure. It is suggested that randomization occur within 48 hours of the scheduled surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 737 0
5042

Funding & Sponsors
Funding source category [1] 3008 0
Commercial sector/Industry
Name [1] 3008 0
Biomimetice Therapeutics Inc
Country [1] 3008 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
BioMimetics Therapeutics Inc
Address
389-A Nichol Mill Lane
Franklin
TN 37067
Country
United States of America
Secondary sponsor category [1] 2698 0
None
Name [1] 2698 0
Address [1] 2698 0
Country [1] 2698 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4966 0
Ethics committee address [1] 4966 0
Ethics committee country [1] 4966 0
Date submitted for ethics approval [1] 4966 0
20/11/2007
Approval date [1] 4966 0
Ethics approval number [1] 4966 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28310 0
Address 28310 0
Country 28310 0
Phone 28310 0
Fax 28310 0
Email 28310 0
Contact person for public queries
Name 11467 0
Heather Neill
Address 11467 0
389-A Nichol Mill Lane
Franklin
TN 37067
Country 11467 0
United States of America
Phone 11467 0
+ 615 236 4911
Fax 11467 0
+ 615 236 4972
Email 11467 0
[email protected]
Contact person for scientific queries
Name 2395 0
Heather Neill
Address 2395 0
389-A Nichol Mill Lane
Franklin
TN 37067
Country 2395 0
United States of America
Phone 2395 0
+ 615 236 4911
Fax 2395 0
+ 615 236 4972
Email 2395 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.