Trial Outcomes & Findings for Cormet Post-PMA Study: New Enrollment (NCT NCT00722007)
NCT ID: NCT00722007
Last Updated: 2019-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
147 participants
Primary outcome timeframe
Month 24+
Results posted on
2019-07-02
Participant Flow
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.
Unit of analysis: Implants
Participant milestones
| Measure |
Post-PMA Study
Implanted with Cormet Hip Resurfacing System after pre-market approval.
|
|---|---|
|
Overall Study
STARTED
|
147 160
|
|
Overall Study
COMPLETED
|
117 128
|
|
Overall Study
NOT COMPLETED
|
30 32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cormet Post-PMA Study: New Enrollment
Baseline characteristics by cohort
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=160 Implants
Cormet Resurfacing Hip System implanted after pre-market approval
|
|---|---|
|
Age, Continuous
|
52.4 years
n=68 Implants
|
|
Sex: Female, Male
Female
|
13 Implants
n=68 Implants
|
|
Sex: Female, Male
Male
|
147 Implants
n=68 Implants
|
|
Region of Enrollment
United States
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=134 Implants
|
|---|---|
|
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
|
104 Implants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=128 Implants
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS Mild
|
8 Implants
|
|
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
|
|
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
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Total HHS missing
|
2 Implants
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS None
|
87 Implants
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS Slight
|
28 Implants
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS Moderate
|
4 Implants
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS Marked
|
0 Implants
|
|
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
|
|
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
Pain HHS missing
|
1 Implants
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Month 24+Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24
Outcome measures
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=160 Implants
|
|---|---|
|
Survival Rate Using Kaplan-Meier Survival Curves
|
155 Implants
|
SECONDARY outcome
Timeframe: Month 24+Outcome measures
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=160 Implants
|
|---|---|
|
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
|
9 Implants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=126 Implants
|
|---|---|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Acetabular Component - I
|
1 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Acetabular Component - II
|
1 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Acetabular Component - III
|
1 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Femoral Component - Superior
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Femoral Component - Tip
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Radiolucency Femoral Component - Inferior
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Superior/Inferior Cup Migration > 4mm
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Medial/Lateral Cup Migration > 4mm
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Varus/Valgus Cup Tilt > 4 degrees
|
0 Implants
|
|
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
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Anteversion of the Head ≥ 5mm
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Retroversion of the Head ≥ 5 mm
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Hypertrophy in Any Zone
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Resorption in Any Zone
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Lysis in Any Zone
|
0 Implants
|
|
The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
Osteolysis
|
0 Implants
|
Adverse Events
Cormet Hip Resurfacing Post-PMA Group
Serious events: 33 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=147 participants at risk
|
|---|---|
|
Cardiac disorders
Heart valve replacement
|
0.68%
1/147
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
1/147
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.68%
1/147
|
|
Infections and infestations
Cellulitis
|
0.68%
1/147
|
|
Infections and infestations
Deep joint infection
|
1.4%
2/147
|
|
Injury, poisoning and procedural complications
Meniscus tear
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hip pseudotumour
|
0.68%
1/147
|
|
Surgical and medical procedures
Acetabular loosening
|
0.68%
1/147
|
|
Surgical and medical procedures
Contralateral hip resurfacing
|
10.2%
15/147
|
|
Surgical and medical procedures
Contralateral revision THR
|
2.0%
3/147
|
|
Surgical and medical procedures
Contralateral revision TKR
|
0.68%
1/147
|
|
Surgical and medical procedures
Contralateral THR
|
4.1%
6/147
|
|
Surgical and medical procedures
Contralateral TKA
|
0.68%
1/147
|
|
Surgical and medical procedures
Femoral loosening
|
0.68%
1/147
|
|
Surgical and medical procedures
Femoral neck fracture
|
3.4%
5/147
|
|
Surgical and medical procedures
Hip dislocation
|
0.68%
1/147
|
Other adverse events
| Measure |
Cormet Hip Resurfacing Post-PMA Group
n=147 participants at risk
|
|---|---|
|
Cardiac disorders
Hypertension
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Hamstring detachment
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Hip pain (operative side)
|
1.4%
2/147
|
|
Injury, poisoning and procedural complications
Meniscus tear
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
Contralateral hip pain
|
1.4%
2/147
|
|
Musculoskeletal and connective tissue disorders
Contralateral OA
|
1.4%
2/147
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
Hip pain (operative side)
|
2.7%
4/147
|
|
Musculoskeletal and connective tissue disorders
Iliopsoas tendonitis
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
IT band friction syndrome
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.7%
4/147
|
|
Musculoskeletal and connective tissue disorders
L5-S1 spondylolisthesis
|
0.68%
1/147
|
|
Surgical and medical procedures
Hip dislocation
|
0.68%
1/147
|
|
Vascular disorders
DVT
|
0.68%
1/147
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will review publications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. If the sponsor determines the publication contains patentable subject matter the embargo can be extended up to 120 days from the time submitted to the sponsor for review. The PI shall agree to accept the sponsor's reasonable comments and suggestions with respect to publications.
- Publication restrictions are in place
Restriction type: OTHER