Arthroplasty, Replacement, Hip
Conditions
Brief summary
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
Detailed description
The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur. In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.
Interventions
DEVICERestoration® Modular Revision Hip System
Restoration® Modular Revision System
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Candidates for cementless revision of a failed femoral prosthesis. * Patients willing to sign the informed consent. * Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations. * Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.
Exclusion criteria
* Patients with ongoing infection. * Patients who are severely immunocompromised. * Patients who are prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stem Survivorship (%) | 5 years | Failure is defined by stem revision for any cause. |
| Femoral Stem Fracture | 5 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgery Femoral Crack/Fracture and Subsidence Rate | Post-op to 5 years | — |
| Radiographic Stability | 5 years | Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view. |
| Harris Hip Score | pre-op and 5 years | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor |
| SF-36 Health Status Survey: Role - Physical | pre-op, 2 year and 5 year | Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the Role-Physical score. |
Countries
United States
Participant flow
Pre-assignment details
137/139 participants/hips enrolled and 17/17 participants/hips censored=120/122 participants/hips started
Participants by arm
| Arm | Count |
|---|---|
| Restoration® Modular All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 8 |
| Overall Study | Did not have surgery | 1 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | No 5 year evaluation | 6 |
| Overall Study | Removal of study device | 3 |
| Overall Study | Site Termination | 24 |
| Overall Study | Unable/Unwilling to return | 6 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Restoration® Modular |
|---|---|
| Age, Continuous | 67.72 years STANDARD_DEVIATION 12.05 |
| Region of Enrollment United States | 120 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 120 |
| serious Total, serious adverse events | 44 / 120 |
Outcome results
Primary
Femoral Stem Fracture
Time frame: 5 years
Population: Participants who received the Restoration Modular Hip System.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration® Modular | Femoral Stem Fracture | 0 femoral stem fractures |
Primary
Stem Survivorship (%)
Failure is defined by stem revision for any cause.
Time frame: 5 years
Population: Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration® Modular | Stem Survivorship (%) | 94.64 stem survivorship percentage at 5 years |
Comparison: This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.p-value: 0.0136Exact Binomial
Secondary
Harris Hip Score
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor
Time frame: pre-op and 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration® Modular | Harris Hip Score | Mean HHS Pre-op N=110 | 46.33 units on a scale | Standard Deviation 16.34 |
| Restoration® Modular | Harris Hip Score | Mean HHS 5 years N=45 | 88.27 units on a scale | Standard Deviation 10.91 |
Comparison: Change from HHS pre-op to HHS 5 yearp-value: <0.0001t-test, 2 sided
Secondary
Post-surgery Femoral Crack/Fracture and Subsidence Rate
Time frame: Post-op to 5 years
Population: Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restoration® Modular | Post-surgery Femoral Crack/Fracture and Subsidence Rate | Post-surgery femoral stem crack/fracture rate % | 1.64 percentage of hips |
| Restoration® Modular | Post-surgery Femoral Crack/Fracture and Subsidence Rate | Femoral subsidence rate % | 1.64 percentage of hips |
Comparison: Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)p-value: <0.0001Exact Binomial
Secondary
Radiographic Stability
Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.
Time frame: 5 years
Population: 41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restoration® Modular | Radiographic Stability | 97.6 percentage of stable hips |
Secondary
SF-36 Health Status Survey: Role - Physical
Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the Role-Physical score.
Time frame: pre-op, 2 year and 5 year
Population: SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restoration® Modular | SF-36 Health Status Survey: Role - Physical | SF-36 Role-Physical Pre-op N=121 | 31.21 units on a scale | Standard Deviation 10.67 |
| Restoration® Modular | SF-36 Health Status Survey: Role - Physical | SF-36 Role-Physical 2 year N=86 | 42.25 units on a scale | Standard Deviation 12.15 |
| Restoration® Modular | SF-36 Health Status Survey: Role - Physical | SF-36 Role-Physical 5 year N=45 | 44.66 units on a scale | Standard Deviation 13.24 |
Comparison: Change from SF-36 Role-Physical pre-op score to 2 and 5 year scoresp-value: <0.0001t-test, 2 sided