The objective of the study is to observe the performance of a new implant during and after surgery. The information from this project will help develop new techniques for using this product and be used to train other surgeons.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duration of the surgery (operating room time)
Blood loss
Complications
Ease of use
Secondary outcome
To define the clinical and radiographic outcome of using Norian Drillable by
evaluating:
1. fracture stabilization and
2. patient function and pain over time.
Background summary
The new implant is a paste that is used to temporarily replace missing bone.
The paste will harden after it is implanted, but it will be replaced by natural
bone over time. The new implant is an improved version of a paste that is
commonly used for the same purpose.
Study objective
The objective of the study is to observe the performance of a new implant
during and after surgery. The information from this project will help develop
new techniques for using this product and be used to train other surgeons.
Study design
Observational study without comparison group, a case-series
Intervention
All patients will receive Norian Drillable to fill the bone void in the tibia
plateau fracture
Study burden and risks
The potential medical risks associated with the new implant are expected to be
the same as the general risks associated with implanting this type of product.
Previous studies with similar implants reported:
Local inflammation - the area around the implant becomes painful and swollen
Infection - the implant becomes infected
Material migration - movement of the implant from the intended implant site
into the surrounding soft tissue
Extrusion - small pieces of implant may cut the skin
Lack of hardening - the material does not harden as anticipated
Material remaining after healing - the implant will dissapear over a period of
years, but the fracture usually heals sooner
Eimattstrasse 3
4436 Oberdorf
CH
Eimattstrasse 3
4436 Oberdorf
CH
Listed location countries
Age
Inclusion criteria
1.Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
2.At least 18 years of age.
3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion criteria
1.Critically ill
2.Mentally ill or mentally disordered
3.Wards of the state
4.Prisoners
5.Refugees
6.In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
7.Active or suspected infection - systemic or local
8.Gustillo classification of 2 or 3
9.Bilateral tibial plateau fractures when both fracture patterns extend into the joint
10.Have an existing calcium metabolism disorder (e.g. hypercalcemia)
11.Chronic renal disease/renal failure
12.Insulin dependent diabetes
13.Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
14.Rheumatoid arthritis or other autoimmune disease.
15.Systemic disease including AIDS, HIV, hepatitis.
16.Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
17.Subjects involved in other studies within the last month, prior to screening.
18.Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ND-AUS-01 |
| CCMO | NL31606.100.10 |