Trial Outcomes & Findings for Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation (NCT NCT01693367)
NCT ID: NCT01693367
Last Updated: 2020-08-13
Results Overview
To assess pain, stiffness, and physical function
TERMINATED
PHASE4
5 participants
12 months after surgery
2020-08-13
Participant Flow
The multicenter international study enrolled patients with distal femur fractures which were either stabilize with a Dynamic Locking Screw or a standard locking screw. The study was stopped due to implant breakages observed after planned implant removals in non-study patients treated with the DLS 5.0mm.
Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits.
Participant milestones
| Measure |
DLS 5.0 (Dynamic Locking Screws)
ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
|
SLS (Standard Locking Screw)
ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
DLS 5.0 (Dynamic Locking Screws)
ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
|
SLS (Standard Locking Screw)
ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
Baseline characteristics by cohort
| Measure |
DLS 5.0 (Dynamic Locking Screws)
n=2 Participants
ORIF with DLS 5.0 (Dynamic Locking Screws)
DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
|
SLS (Standard Locking Screw)
n=3 Participants
ORIF with SLS (Standard locking screw)
SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
55 years
n=7 Participants
|
60.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after surgeryPopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
To assess pain, stiffness, and physical function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks ± 7 days, 6 months ± 30 daysPopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgeryPopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgeryPopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
Assessment of passive ROM of the knee (flexion - extension)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weekly measurement at homePopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
Assessment of the timepoint when the patient : * can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds * can walk without walking aid * has no intake of analgesics * has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgeryPopulation: Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.
To assess pain, stiffness, and physical function
Outcome measures
Outcome data not reported
Adverse Events
DLS 5.0 (Dynamic Locking Screws)
SLS (Standard Locking Screw)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Operations Manager of Clinical Investigation and Documentation
AO Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place