An interventional study of Cormet Hip Resurfacing in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Corin. Completed at 6 sites in United States. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Corin · Not applicable, Interventional, and Treatment
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
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).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 147 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Corin is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
hip resurfacing
Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant
Also known as: Corin Cormet
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+
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+
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+
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
Time frame: Month 24+
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+
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.
| Milestone | Post-PMA Study |
|---|---|
| Started | 147 |
| Completed | 117 |
| Not completed | 30 |
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.
| Implants | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 | 104 |
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)
| Implants | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Total HHS Excellent (90-100) | 109 |
| Total HHS Good (80-89) | 10 |
| Total HHS Fair (70-79) | 6 |
| Total HHS Poor (<70) | 1 |
| Total HHS missing | 2 |
| Pain HHS None | 87 |
| Pain HHS Slight | 28 |
| Pain HHS Mild | 8 |
| Pain HHS Moderate | 4 |
| Pain HHS Marked | 0 |
| Pain HHS Totally Disabled | 0 |
| Pain HHS missing | 1 |
| Function HHS Normal (40-47) | 127 |
| Function HHS Mild Dysfunction (30=<39) | 1 |
| Function HHS Moderate Dysfunction (20=<29) | 0 |
| Function HHS Severe Dysfunction (10=<19) | 0 |
| Function HHS Disabled (0=<9) | 0 |
Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24
| Implants | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Survival Rate Using Kaplan-Meier Survival Curves | 155 |
| Implants | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events | 9 |
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
| Implants | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Radiolucency Acetabular Component - I | 1 |
| Radiolucency Acetabular Component - II | 1 |
| Radiolucency Acetabular Component - III | 1 |
| Radiolucency Femoral Component - Superior | 0 |
| Radiolucency Femoral Component - Tip | 0 |
| Radiolucency Femoral Component - Inferior | 0 |
| Superior/Inferior Cup Migration > 4mm | 0 |
| Medial/Lateral Cup Migration > 4mm | 0 |
| Varus/Valgus Cup Tilt > 4 degrees | 0 |
| Stem subsidence of > 4mm and stem tilt of > 4° | 0 |
| Anteversion of the Head ≥ 5mm | 0 |
| Retroversion of the Head ≥ 5 mm | 0 |
| Hypertrophy in Any Zone | 0 |
| Resorption in Any Zone | 0 |
| Lysis in Any Zone | 0 |
| Osteolysis | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cormet Hip Resurfacing Post-PMA Group | 0/147 (0%) | 33/147 (22.4%) | 20/147 (13.6%) |
| Event | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Contralateral hip resurfacingSurgical and medical procedures | 15/147 |
| Contralateral THRSurgical and medical procedures | 6/147 |
| Femoral neck fractureSurgical and medical procedures | 5/147 |
| Contralateral revision THRSurgical and medical procedures | 3/147 |
| Deep joint infectionInfections and infestations | 2/147 |
| Heart valve replacementCardiac disorders | 1/147 |
| Myocardial infarctionCardiac disorders | 1/147 |
| Inguinal herniaGastrointestinal disorders | 1/147 |
| CellulitisInfections and infestations | 1/147 |
| Meniscus tearInjury, poisoning and procedural complications | 1/147 |
| Event | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Hip pain (operative side)Musculoskeletal and connective tissue disorders | 4/147 |
| Knee painMusculoskeletal and connective tissue disorders | 4/147 |
| Hip pain (operative side)Injury, poisoning and procedural complications | 2/147 |
| Contralateral hip painMusculoskeletal and connective tissue disorders | 2/147 |
| Contralateral OAMusculoskeletal and connective tissue disorders | 2/147 |
| HypertensionCardiac disorders | 1/147 |
| Fibula fractureInjury, poisoning and procedural complications | 1/147 |
| Hamstring detachmentInjury, poisoning and procedural complications | 1/147 |
| Meniscus tearInjury, poisoning and procedural complications | 1/147 |
| Groin painMusculoskeletal and connective tissue disorders | 1/147 |
| Age, Continuous(years) | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Mean | 52.4 (32 to 65) |
| Sex: Female, Male(Implants) | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| Female | 13 |
| Male | 147 |
| Region of Enrollment(participants) | Cormet Hip Resurfacing Post-PMA Group |
|---|---|
| United States | 147 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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