Arthroplasty, Replacement, Hip
Conditions
Keywords
[E04.555.110.110.110]
Brief summary
The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.
Detailed description
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria. The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.
Interventions
DEVICESecur-Fit Advanced Hip Stem
Straight femoral stem intended for cementless, press-fit application.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form. * Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation. * Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease. * Patient is a candidate for primary total hip arthroplasty. * Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
* Patient has previously undergone open surgical intervention on the operative hip. * Patient has a prior femoral fracture, with or without deformity, on the operative side. * Patient has an existing total hip replacement on the contralateral side. * Patient requires simultaneous bilateral total hip replacement. * Patient has a Body Mass Index (BMI) \> 45. * Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device. * Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Patient has a known sensitivity to device materials. * Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture | 5 years | The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Revision and Removal Rate | 10 years | To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature. |
| Rate of Device-related Femoral Fracture | 30 days | To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature. |
| Final Seating of Femoral Stem | Intraoperative | To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating. |
Countries
United States
Participant flow
Recruitment details
There were 326 hips/participants enrolled in this study (no bilateral cases).
Pre-assignment details
Of the 326 hips/participants enrolled and consented, there were 12 cases that were censored due to not having the study device implanted, surgery cancelled or due to an inclusion or exclusion violation. Therefore, 314 hips/participants (there were no bilateral cases) are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.
Participants by arm
| Arm | Count |
|---|---|
| Secur-Fit Advanced Secur-Fit Advanced Hip Stem
Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application. | 314 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Censored because of inclusion exclusion violation | 3 |
| Overall Study | Censored because study device not implanted | 6 |
| Overall Study | Censored because surgery not performed | 3 |
| Overall Study | Death | 8 |
| Overall Study | Investigative Site Terminated | 35 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Sponsor terminated study | 175 |
| Overall Study | Withdrawal by Subject | 33 |
Baseline characteristics
| Characteristic | Secur-Fit Advanced |
|---|---|
| Age, Continuous | 61.81 years |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 286 Participants |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 314 | 8 / 314 |
| other Total, other adverse events | 27 / 314 | 0 / 314 |
| serious Total, serious adverse events | 14 / 314 | 4 / 314 |
Outcome results
Primary
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.
Time frame: 5 years
Population: Participants/hips with available data up to 5 years or at the time of early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secur-Fit Advanced | Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture | 0 Participants |
Secondary
All-cause Revision and Removal Rate
To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature.
Time frame: 10 years
Population: Participants/hips with available data up to 10 years or at the time of early study termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secur-Fit Advanced | All-cause Revision and Removal Rate | 6 Participants |
Secondary
Final Seating of Femoral Stem
To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating.
Time frame: Intraoperative
Population: Participants/hips with available data intraoperatively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secur-Fit Advanced | Final Seating of Femoral Stem | Flush seating on femoral stem | 223 Participants |
| Secur-Fit Advanced | Final Seating of Femoral Stem | Proud seating of femoral stem | 82 Participants |
| Secur-Fit Advanced | Final Seating of Femoral Stem | Countersunk seating of femoral stem | 9 Participants |
Secondary
Rate of Device-related Femoral Fracture
To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature.
Time frame: 30 days
Population: Participants/hips with available data from surgery to 30 days postoperative.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secur-Fit Advanced | Rate of Device-related Femoral Fracture | 1 Participants |