36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
CompletedNAResults postedLast updated 10 April 2019
What this trial tests
NA trial testing 36 mm ceramic head on a ceramic acetabular liner in Non-inflammatory Degenerative Joint Disease in 243 participants. Completed in 1 July 2013.
Adults 20 to 75, any sex, with Non-inflammatory Degenerative Joint Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Harris Hip ScorePrimary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
Group
Value
95% CI
36 mm Ceramic-on-ceramic
95.6
± 8.8
28 mm Ceramic-on-polyethylene
94.9
± 8.9
Harris Hip Subscale Score: PainSecondary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
41.4
± 6.3
28 mm Ceramic-on-polyethylene
41.1
± 5.7
Harris Hip Subscale Score: FunctionSecondary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
32.1
± 2.5
28 mm Ceramic-on-polyethylene
31.6
± 4.0
Harris Hip Subscale Score: ActivitiesSecondary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
13.2
± 1.4
28 mm Ceramic-on-polyethylene
13.0
± 1.7
Harris Hip Subscale Score: DeformitySecondary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
4.0
± 0
28 mm Ceramic-on-polyethylene
4.0
± 0
Harris Hip Subscale Score: Range of MotionSecondary· At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
4.9
± 0.1
28 mm Ceramic-on-polyethylene
4.9
± 0.2
Harris Hip Score Longitudinal AnalysisSecondary· 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.
6 week Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
52.6
± 10.9
28 mm Ceramic-on-polyethylene
52.0
± 9.5
6 month Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
93.1
± 10.0
28 mm Ceramic-on-polyethylene
93.4
± 9.7
12 month Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
95.5
± 6.5
28 mm Ceramic-on-polyethylene
95.2
± 7.6
24 month Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
95.7
± 8.2
28 mm Ceramic-on-polyethylene
93.7
± 10.2
36 month Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
96.6
± 6.8
28 mm Ceramic-on-polyethylene
97.0
± 4.6
48 month Total Harris Hip Score
Group
Value
95% CI
36 mm Ceramic-on-ceramic
94.6
± 10.1
28 mm Ceramic-on-polyethylene
93.5
± 11.1
Proportion of Composite SuccessesSecondary· At final follow-up visit, 24 months or later, up to 72 months
A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.
Group
Value
95% CI
36 mm Ceramic-on-ceramic
90.5
28 mm Ceramic-on-polyethylene
90.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by DePuy Orthopaedics
Last refreshed: 10 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00953719.