Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
Brief summary
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Detailed description
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
Interventions
DEVICECormet Hip Resurfacing
Cormet Hip Resurfacing implant
Sponsors
Corin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female patient who meets eligibility criteria consistent with product labeling * skeletally mature * mentally capable of completing follow-up forms * Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation * Has been deemed a candidate for hip replacement by diagnosis of the investigator * consented to participate in the clinical study
Exclusion criteria
* Patient with active or suspected infection in or around the hip joint; * Patient with bone stock inadequate to support the device * Patient with severe osteopenia * Patient with a family history of severe osteoporosis or severe osteopenia; * Patient with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade) * Patient with multiple cysts of the femoral head (\>1cm) * In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock. * Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery; * Female of child-bearing age due to unknown effects on the fetus of metal ion release. * Patient with known moderate or severe renal insufficiency; * Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids; * Patient who is severely overweight; * Patient with known or suspected metal sensitivity (e.g., jewelry).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 | Month 24+ | Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Month 24+ | All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (\<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=\<39); Moderate Dysfunction (20=\<29); Severe Dysfunction (10=\<19); Disabled (0=\<9) |
| Survival Rate Using Kaplan-Meier Survival Curves | Month 24+ | Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24 |
| Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events | Month 24+ | — |
| The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Month 24+ | The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration \> 4mm; Medial/Lateral Migration \> 4mm; Varus/Valgus Tilt \> 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component \> 4mm and Stem tilting \> 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis |
Countries
United States
Participant flow
Recruitment details
Between 24 Apr 2008 and 21 Dec 2011, 147 participants were enrolled in 6 study hospitals, with 160 Cormet resurfacing implants in 134 unilateral and 13 bilateral procedures.
Participants by arm
| Arm | Count |
|---|---|
| Cormet Hip Resurfacing Post-PMA Group Cormet Resurfacing Hip System implanted after pre-market approval | 147 |
| Cormet Hip Resurfacing Post-PMA Group Cormet Resurfacing Hip System implanted after pre-market approval | 160 |
| Total | 307 |
Baseline characteristics
| Characteristic | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Age, Continuous | 52.4 years |
| Region of Enrollment United States | 147 participants |
| Sex: Female, Male Female | 13 Implants |
| Sex: Female, Male Male | 147 Implants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 147 |
| other Total, other adverse events | 20 / 147 |
| serious Total, serious adverse events | 33 / 147 |
Outcome results
Primary
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.
Time frame: Month 24+
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 | 104 Implants |
Secondary
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (\<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=\<39); Moderate Dysfunction (20=\<29); Severe Dysfunction (10=\<19); Disabled (0=\<9)
Time frame: Month 24+
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Total HHS Excellent (90-100) | 109 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Total HHS Good (80-89) | 10 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Total HHS Fair (70-79) | 6 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Total HHS Poor (<70) | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Total HHS missing | 2 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS None | 87 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS Slight | 28 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS Mild | 8 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS Moderate | 4 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS Marked | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS Totally Disabled | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Pain HHS missing | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Function HHS Normal (40-47) | 127 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Function HHS Mild Dysfunction (30=<39) | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Function HHS Moderate Dysfunction (20=<29) | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Function HHS Severe Dysfunction (10=<19) | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | Function HHS Disabled (0=<9) | 0 Implants |
Secondary
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
Time frame: Month 24+
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events | 9 Implants |
Secondary
Survival Rate Using Kaplan-Meier Survival Curves
Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24
Time frame: Month 24+
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | Survival Rate Using Kaplan-Meier Survival Curves | 155 Implants |
Secondary
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration \> 4mm; Medial/Lateral Migration \> 4mm; Varus/Valgus Tilt \> 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component \> 4mm and Stem tilting \> 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis
Time frame: Month 24+
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Acetabular Component - I | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Acetabular Component - II | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Acetabular Component - III | 1 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Femoral Component - Superior | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Femoral Component - Tip | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Radiolucency Femoral Component - Inferior | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Superior/Inferior Cup Migration > 4mm | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Medial/Lateral Cup Migration > 4mm | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Varus/Valgus Cup Tilt > 4 degrees | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Stem subsidence of > 4mm and stem tilt of > 4° | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Anteversion of the Head ≥ 5mm | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Retroversion of the Head ≥ 5 mm | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Hypertrophy in Any Zone | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Resorption in Any Zone | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Lysis in Any Zone | 0 Implants |
| Cormet Hip Resurfacing Post-PMA Group | The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively | Osteolysis | 0 Implants |