N/A
N=33
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Tibial Fractures
Bottom Line
View on ClinicalTrials.gov: NCT01132508 ↗Enrolled (actual)
33
Serious AEs
45.5%
Results posted
Jun 2015
Primary outcome: Primary: Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment — 107.0 Minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Norian Drillable Bone Void Filler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synthes GmbH
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment |
107.0 | — |
| PRIMARY Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment |
114.0 | — |
| PRIMARY Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device |
21 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Drill |
27; 1; 0; 5 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: K-wire |
5; 0; 0; 28 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Tap |
8; 0; 0; 25 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion |
29; 1; 0; 3 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing |
6; 16; 3; 6; 1; 0 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling |
4; 15; 6; 7; 0; 0 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties |
6; 9; 10; 6; 0; 1 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure |
2; 15; 6; 9; 0; 0 | — |
| PRIMARY Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use |
6; 11; 10; 4; 0; 1 | — |
| PRIMARY Surgeons Overall Satisfaction With Norian Drillable |
21; 2; 6; 1; 0; 2 | — |
| SECONDARY Pain and Function Assessed With the Lysholm Knee Scale |
52.0; 66.7; 70.6; 75.0; 67.8; 73.5 | — |
| SECONDARY Radiographic Parameters: Depression at Baseline |
0; 27; 1 | — |
| SECONDARY Radiographic Parameters: Depression at Surgery |
15; 12; 1 | — |
| SECONDARY Radiographic Parameters: Depression at 6 Weeks |
22; 4; 2 | — |
| SECONDARY Radiographic Parameters: Depression at 12 Weeks |
16; 7; 5 | — |
| SECONDARY Radiographic Parameters: Depression at 26 Weeks |
16; 5; 7 | — |
| SECONDARY Radiographic Parameters:: Depression at 52 Weeks |
12; 8; 8 | — |
| SECONDARY Radiographic Parameters: Depression at 78 Weeks |
13; 8; 7 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at Baseline |
6; 21; 1 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at Surgery |
20; 7; 1 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at 6 Weeks |
24; 2; 2 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at 12 Weeks |
23; 0; 5 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at 26 Weeks |
20; 1; 7 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at 52 Weeks |
20; 0; 8 | — |
| SECONDARY Radiographic Parameters: Condylar Widening at 78 Weeks |
20; 0; 8 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at Baseline |
16; 9; 3 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at Surgery |
23; 4; 1 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks |
24; 2; 2 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks |
21; 3; 4 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks |
19; 2; 7 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks |
17; 3; 8 | — |
| SECONDARY Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks |
17; 3; 8 | — |
| SECONDARY Knee Function and Stability: Extension at Baseline |
16; 10; 2 | — |
| SECONDARY Knee Function and Stability: Extension at 6 Weeks |
20; 6; 2 | — |
| SECONDARY Knee Function and Stability: Extension at 12 Weeks |
21; 2; 5 | — |
| SECONDARY Knee Function and Stability: Extension at 26 Week |
18; 3; 7 | — |
| SECONDARY Knee Function and Stability: Extension at 52 Weeks |
20; 4; 4 | — |
| SECONDARY Knee Function and Stability: Extension at 78 Weeks |
19; 2; 7 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at Baseline |
3; 4; 8; 5; 1; 3 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at 6 Weeks |
4; 6; 13; 2; 2; 0 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at 12 Weeks |
10; 9; 2; 0; 2; 0 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at 26 Weeks |
4; 11; 4; 1; 1; 0 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at 52 Weeks |
16; 5; 1; 1; 1; 0 | — |
| SECONDARY Knee Function and Stability: Total Range of Motion at 78 Weeks |
10; 9; 0; 2; 0; 0 | — |
| SECONDARY Knee Function and Stability: Extension Stability at Baseline |
13; 6; 3; 1; 5 | — |
| SECONDARY Knee Function and Stability: Extension Stability at 6 Weeks |
23; 3; 1; 0; 1 | — |
| SECONDARY Knee Function and Stability: Extension Stability at 12 Weeks |
22; 1; 0; 0; 5 | — |
| SECONDARY Knee Function and Stability: Extension Stability at 26 Weeks |
20; 0; 1; 0; 7 | — |
| SECONDARY Knee Function and Stability: Extension Stability at 52 Weeks |
22; 1; 1; 0; 4 | — |
| SECONDARY Knee Function and Stability: Extension Stability at 78 Weeks |
17; 3; 1; 0; 7 | — |
Summary
Case series of tibial plateau fractures using Norian Drillable.
Eligibility Criteria
Inclusion Criteria
- Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
- At least 18 years of age.
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
- Signed informed consent.
Exclusion Criteria
- Critically ill
- Mentally ill or mentally disordered
- Wards of the state
- Prisoners
- Refugees
- In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
- Active or suspected infection - systemic or local
- Gustillo classification of 2 or 3
- Bilateral tibial plateau fractures when both fracture patterns extend into the joint
- Have an existing calcium metabolism disorder (e.g. hypercalcemia)
- Chronic renal disease/renal failure
- Insulin dependent diabetes
- Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
- Rheumatoid arthritis or other autoimmune disease.
- Systemic disease including AIDS, HIV, hepatitis.
- 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.
- Subjects involved in other studies within the last month, prior to screening.
- 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.
Data sourced from ClinicalTrials.gov (NCT01132508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.