Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
This study has been terminated.
(Terminated due to limited enrollment and follow up.)
Sponsor:
DePuy Orthopaedics
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00306917
First received: March 23, 2006
Last updated: December 1, 2011
Last verified: December 2011
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Results First Received: January 29, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Avascular Necrosis Acute Fracture |
| Interventions: |
Device: non-coated femoral hip stem Device: coated femoral hip stem |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment began in September 2002 and ended June 2006. Study subjects were recruited and enrolled in medical clinics by orthopaedic surgeons at eight investigational sites. Each site could enroll a maximum of 50 subjects. Recruitment was based on the inclusion and exclusion criteria as indicated in the study protocol. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Immediately before surgery, the implant type was determined according to the randomization schedule. Enrolled subjects may have been excluded from the trial before assignment to the study arm based upon results of pre-operative clinical evaluations and radiographs that would exclude a subject based on exclusion criteria in the study protocol. |
Reporting Groups
| Description | |
|---|---|
| DuoFix HA | The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
Participant Flow: Overall Study
| DuoFix HA | Porocoat Porous Coated | |
|---|---|---|
| STARTED | 121 [1] | 124 [1] |
| Postoperative to 6 Month Follow up | 93 | 100 |
| 12 Month Follow | 86 | 94 |
| 24 Month Follow up | 60 | 71 |
| 36 Month Follow up | 56 | 42 |
| 48 Month Follow up | 29 | 22 |
| 60 Month Follow up | 13 | 15 |
| COMPLETED | 13 | 15 |
| NOT COMPLETED | 108 | 109 |
| [1] | 400 subjects were to be followed for 5 years; due to slow enrollment study closed early with 245. |
|---|
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| DuoFix HA | The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| Porocoat Porous Coated | The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading. |
| Total | Total of all reporting groups |
Baseline Measures
| DuoFix HA | Porocoat Porous Coated | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
121 | 124 | 245 |
|
Age
[units: years] Mean ± Standard Deviation |
64.5 ± 8.2 | 63.2 ± 9.2 | 63.8 ± 8.7 |
|
Gender
[units: participants] |
|||
| Female | 67 | 64 | 131 |
| Male | 54 | 60 | 114 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 121 | 124 | 245 |
Outcome Measures
