Distal Femur Fractures
Conditions
Keywords
Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw, WOMAC
Brief summary
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
Interventions
DEVICEDLS 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
DEVICESLS (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)
Sponsors
AO Innovation Translation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* 21 years and older * Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty * Ability to walk independently prior to injury * Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP) * Willing and able to comply with post-operative protocol and return for follow-up. * Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation * Signed informed consent
Exclusion criteria
* Additional ipsi- or contralateral lower extremity fracture * Any kind of implant at the ipsilateral proximal femur * Pre-existing malunion or nonunion of the ipsilateral lower extremity * Segmental bone defect requiring bone grafting * More than 4 weeks between injury and surgery * Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis) * Polytrauma * Active malignancy * Any not medically managed severe systemic disease * Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the study period * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Index (WOMAC) | 12 months after surgery | To assess pain, stiffness, and physical function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up-and-go Test (TUG) | 12 weeks ± 7 days, 6 months ± 30 days | 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. |
| Quality of Life (EuroQol-5D) | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | — |
| Range of Motion (ROM) | 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | Assessment of passive ROM of the knee (flexion - extension) |
| Full Weight-bearing Status | weekly measurement at home | 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 |
| WOMAC | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | To assess pain, stiffness, and physical function |
Countries
Austria, Germany, Switzerland, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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) | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | DLS 5.0 (Dynamic Locking Screws) | SLS (Standard Locking Screw) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 68.5 years | 55 years | 60.4 years |
| Region of Enrollment Germany | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Switzerland | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Western Ontario and McMaster Universities Index (WOMAC)
To assess pain, stiffness, and physical function
Time frame: 12 months after surgery
Population: 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.
Secondary
Full Weight-bearing Status
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
Time frame: weekly measurement at home
Population: 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.
Secondary
Quality of Life (EuroQol-5D)
Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Population: 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.
Secondary
Range of Motion (ROM)
Assessment of passive ROM of the knee (flexion - extension)
Time frame: 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Population: 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.
Secondary
Timed Up-and-go Test (TUG)
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.
Time frame: 12 weeks ± 7 days, 6 months ± 30 days
Population: 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.
Secondary
WOMAC
To assess pain, stiffness, and physical function
Time frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Population: 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.