Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade III Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade IV Subcapital Fracture of Femoral Neck
Conditions
Keywords
Cannulated Screws, Lag Screws, Compression Screws, Telescoping Lag Screws, Cortical Screws, Hip Fracture Plate
Brief summary
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Detailed description
Primary Endpoint: • Revision rate due to device related complication(s) or non-union of the femur. Secondary Endpoints: • Radiographic and clinical fracture healing of the proximal femur using standard scoring methods.
Interventions
DEVICETHP Hip Fracture Plating System with telescoping lag screws
The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be 18 years of age or older. * Patient must be eligible for an open reduction and internal fixation of the proximal femur. * Patient must have an intracapsular or intertrochanteric fracture. * Patient must have need for alignment, stabilization, and reduction of bone fractures. * Patient must have ability and willingness to follow postoperative care instructions until healing is complete. * Patient must be in good nutritional state. * Patient must be able and willing to sign the IRB/EC approved informed consent.
Exclusion criteria
* Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient is known to be pregnant or breastfeeding. * Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent. * Infection. * Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone. * Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. * Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device. * Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Revision | 6 weeks | Revision rate due to device related complication(s) or non-union of the femur. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic Fracture Healing of the Femur (RUSH) | 6 weeks | Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing). |
| Average FIX-IT Score (Clinical Fracture Healing of the Femur) | 6 weeks | The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points. |
| Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur) | 6 weeks | The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). |
| Average VAS Pain Score | 6 weeks | VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THP Hip Fracture Plating System THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Study Termination | 1 |
Baseline characteristics
| Characteristic | THP Hip Fracture Plating System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 83 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Number of Participants With a Revision
Revision rate due to device related complication(s) or non-union of the femur.
Time frame: 6 weeks
Population: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THP Hip Fracture Plating System | Number of Participants With a Revision | 0 Participants |
Secondary
Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
Time frame: 6 weeks
Population: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THP Hip Fracture Plating System | Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur) | 6 weeks - Health Status | 75 score on a scale | Standard Deviation 0 |
| THP Hip Fracture Plating System | Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur) | 6 weeks - EQ-5D Score | .456 score on a scale | Standard Deviation 0 |
Secondary
Average FIX-IT Score (Clinical Fracture Healing of the Femur)
The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.
Time frame: 6 weeks
Population: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THP Hip Fracture Plating System | Average FIX-IT Score (Clinical Fracture Healing of the Femur) | 3 score on a scale | Standard Deviation 0 |
Secondary
Average VAS Pain Score
VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\])
Time frame: 6 weeks
Population: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THP Hip Fracture Plating System | Average VAS Pain Score | 16 score on a scale | Standard Deviation 0 |
Secondary
Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).
Time frame: 6 weeks
Population: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THP Hip Fracture Plating System | Number of Participants With Radiographic Fracture Healing of the Femur (RUSH) | 1 Participants |