Clinical Trial Results:
A prospective randomised controlled trial on the use of BMP-7 (Bone Morphogenetic Protein-7) (OP-1®) and demineralised bone matrix (DBM) in tibial non-union.
|
Summary
|
|
EudraCT number |
2006-006727-39 |
Trial protocol |
BE |
Global end of trial date |
07 Jul 2012
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
11 Oct 2022
|
First version publication date |
11 Oct 2022
|
Other versions |
|
Summary report(s) |
Statement of discontinuation |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
AGO/2006/012
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Ghent University Hospital
|
||
Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
|
||
Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
07 Jul 2012
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
07 Jul 2012
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To investigate the clinical and radiological outcome of tibial diaphysary non-unions in patients surgically treated with adjunct use of BMP-7 compared to the adjunct use of demineralized bone matrix (DBM).
|
||
Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Oct 2007
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belgium: 2
|
||
Worldwide total number of subjects |
2
|
||
EEA total number of subjects |
2
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
2
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
3 patients were screened from 18-10-2007 till 07-07-2012. 2 patients were enrolled. 2 patients were randomised. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Inclusion criteria: - Diaphysary tibial non-unions will be included (minimum 9 months after first surgery) - ASA 1 and ASA 2 - Gap length/bone contact detected (cms) (1-5 cm): largest cortical gap in any radiographic incidence - Agrees to participate in post-operative evaluations and required rehabilitation regimen | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Overall Trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
The evaluation of the radiographic images will be done by an independent blinded radiologist of the University Hospital of Ghent. The clinical observation of the primary endpoints a 9 months will be performed by an independent blinded clinician. The patient will be blinded as far as possible from group assignment. On several occasions the patient will be asked whether or not he knows what product was used on him. By this we will be able to monitor which patients remain blinded.
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Control arm | |||||||||
Arm description |
Control group treated with allografts and Demineralised Bone Matrix (DBM). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Accell Plus
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
Demineralised Bone Matrix (DBM)
|
|||||||||
Pharmaceutical forms |
Powder for implantation suspension
|
|||||||||
Routes of administration |
Intraosseous use
|
|||||||||
Dosage and administration details |
Accell Plus (before: Connexus) is available in 1 ml; 2.5ml, 5 ml, 10 ml of gel or putty. It consists of 70% of human DBM (which is mainly collagen type 1) an 30 % polaxamer, a reverse phase medium that is more viscous at higher temperatures and improves handling. The polaxamer is quickly metabolised and renally excreted.
In this setting, use of 5 ml dose of Accell Plus and in some with bone defects of a larger size, the need may exist to use a 10 ml dose. This is the maximum quantity of DBM allowed in this study.
The product is placed directly in the dry fracture site after debridement during open surgery.
|
|||||||||
|
Arm title
|
Treatment arm | |||||||||
Arm description |
Treatment group treated with allografts and Morphogenetic Protein-7 (BMP-7) (OP-1®). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Osigraft
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
BMP-7, OP-1
|
|||||||||
Pharmaceutical forms |
Powder for implantation suspension
|
|||||||||
Routes of administration |
Intraosseous use
|
|||||||||
Dosage and administration details |
Maximum of 2 doses
Total dose, 2 g gram(s)
Active substance: eptotermin alfa
The needed dose is prepared in a sterile manner and transferred to the sterile field. The product is placed directly in the dry fracture site after debridement during open surgery. Special attention is needed to make sure that the product is not irrigated away or sucked out.
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control arm
|
||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Control group treated with allografts and Demineralised Bone Matrix (DBM). | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment arm
|
||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Treatment group treated with allografts and Morphogenetic Protein-7 (BMP-7) (OP-1®). | ||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Control arm
|
||
Reporting group description |
Control group treated with allografts and Demineralised Bone Matrix (DBM). | ||
Reporting group title |
Treatment arm
|
||
Reporting group description |
Treatment group treated with allografts and Morphogenetic Protein-7 (BMP-7) (OP-1®). | ||
|
||||||||||
End point title |
Repeated surgery [1] | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
N/A
|
|||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was done as only 2 patienst participated in the study |
||||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
(Surgical) complications | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
N/A
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
Overall study
|
||
Assessment type |
Non-systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
24
|
||
| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients. |
|||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
30 Oct 2006 |
Type of amendment: amendment to information in the CT application form, amendment to the protocol
Reasons for the substantial amendment: changes in safety and integrity of trial subjects, changes in conduct or management of the trial
Changes in inclusion criteria have been made: patient can be included into the study minimum 9 months after first surgery instead of 9 months after last major surgery. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| This study was prematurely closed due to inclusion criteria that were too stringent. | |||
