SPD: Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement
Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Terminated
CT.gov ID
NCT00306917
Collaborator
(none)
245
1
2
74.9
3.3
Study Details
Study Description
Brief Summary
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.
Study Design
Study Type:
Interventional
Actual Enrollment
:
245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
Actual Study Start Date
:
Nov 1, 2002
Actual Primary Completion Date
:
Jan 29, 2009
Actual Study Completion Date
:
Jan 29, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 DuoFix HA |
Device: non-coated femoral hip stem
total hip replacement
Other Names:
|
| Active Comparator: 2 Porocoat porous coated |
Device: coated femoral hip stem
total hip replacement
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Harris Hip Score (HHS) [Preoperative, 6, 12, 24, 36, 48, and 60 months]
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. 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 comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.
Secondary Outcome Measures
- Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. [Postoperative, 6, 12, 24, 36, 48 and 60 months]
Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency > 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p < .10, Spot-Welds (Lateral View) p < .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View)
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Primary total hip replacement
-
Patient age less than or equal to 75
-
Sufficient bone stock to support prosthesis
Exclusion Criteria:
-
Previous hip replacement
-
Significant angular/bony deformity
-
Active joint sepsis
-
Metal allergy
-
Renal transplant
-
Psychosocial disease
-
Neurological disease/musculoskeletal disease that may affect weight-bearing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DePuy Orthopaedics | Warsaw | Indiana | United States | 46581 |
Sponsors and Collaborators
- DePuy Orthopaedics
Investigators
- Principal Investigator: David A Fisher, MD, Orthopaedics Indianapolis
- Principal Investigator: J W Mesko, MD, Michigan Orthopaedics Center
- Principal Investigator: Paul Perona, MD, St Margaret's Hospital Family Orthopaedics
- Principal Investigator: Stephan B Lowe, MD, Orthopaedic Specialists of the Carolinas
- Principal Investigator: Donald L Pomeroy, MD, Pomeroy & Reddy
- Principal Investigator: Nithin Reddy, MD, Pomeroy & Reddy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00306917
Other Study ID Numbers:
- SPD
First Posted:
Mar 27, 2006
Last Update Posted:
Jul 19, 2022
Last Verified:
Jun 1, 2022
Keywords provided by DePuy Orthopaedics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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 Detail | 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. |
| Arm/Group Title | DuoFix HA | Porocoat Porous Coated |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 121 | 124 |
| 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 |
Baseline Characteristics
| Arm/Group Title | DuoFix HA | Porocoat Porous Coated | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 121 | 124 | 245 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
64.5
(8.2)
|
63.2
(9.2)
|
63.8
(8.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
67
55.4%
|
64
51.6%
|
131
53.5%
|
| Male |
54
44.6%
|
60
48.4%
|
114
46.5%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
121
100%
|
124
100%
|
245
100%
|
Outcome Measures
| Title | Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. |
|---|---|
| Description | Medical imaging as a secondary outcome inclusive of all post-operative intervals for all participants at study closure. This measure is a percentage of the overall Participants with a specific radiographic outcome. Measurements were made by an Independent Radiographic Reviewer (IRR) and include assessments made based on protocol defined radiographic success criteria that includes Subsidence (10 mm), Osseointegration, Radiolucency > 2 mm in any zone, Complete Circumferential Radiolucencies, Spot-Welds (AP View) p < .10, Spot-Welds (Lateral View) p < .10, Cortical Hypertrophy (AP View), Cortical Hypertrophy (Lateral View) |
| Time Frame | Postoperative, 6, 12, 24, 36, 48 and 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | DuoFix HA | Porocoat Porous Coated |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 121 | 124 |
| Subsidence (10 mm) |
1
0.8%
|
0
0%
|
| Osseointegration |
82
67.8%
|
80
64.5%
|
| Radiolucency > 2 mm in any zone |
0
0%
|
0
0%
|
| Complete Circumferential Radiolucencies |
0
0%
|
0
0%
|
| Spot-Welds (AP View) p < .10 |
23
19%
|
14
11.3%
|
| Spot-Welds (Lateral View) p < .10 |
8
6.6%
|
3
2.4%
|
| Cortical Hypertrophy (AP View) |
12
9.9%
|
12
9.7%
|
| Cortical Hypertrophy (Lateral View) |
3
2.5%
|
4
3.2%
|
| Title | Harris Hip Score (HHS) |
|---|---|
| Description | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. 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 comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction. |
| Time Frame | Preoperative, 6, 12, 24, 36, 48, and 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores. |
| Arm/Group Title | DuoFix HA | Porocoat Porous Coated |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 121 | 124 |
| Preoperative HHS |
49.9
(13.4)
|
51.2
(14.0)
|
| Postoperative to 6 Month HHS |
90.2
(10.3)
|
91.6
(8.3)
|
| 12 Month HHS |
92.8
(7.9)
|
92.3
(11.6)
|
| 24 Month HHS |
93.3
(7.8)
|
93.5
(9.7)
|
| 36 Month HHS |
94.0
(8.5)
|
93.8
(9.4)
|
| 48 Month HHS |
91.8
(12.2)
|
95.5
(10.5)
|
| 60 Month HHS |
93.8
(7.9)
|
93.6
(7.8)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | DuoFix HA | Porocoat Porous Coated | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| DuoFix HA | Porocoat Porous Coated | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DuoFix HA | Porocoat Porous Coated | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/121 (2.5%) | 4/124 (3.2%) | ||
| Cardiac disorders | ||||
| Cardiovascular Arrhythmia | 0/121 (0%) | 0 | 1/124 (0.8%) | 1 |
| Infections and infestations | ||||
| Infection: Deep | 1/121 (0.8%) | 1 | 1/124 (0.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Dislocation | 1/121 (0.8%) | 2 | 0/124 (0%) | 0 |
| Liner failure: dislocation | 1/121 (0.8%) | 1 | 0/124 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Hematoma | 0/121 (0%) | 0 | 1/124 (0.8%) | 1 |
| Infection: Superficial | 0/121 (0%) | 0 | 1/124 (0.8%) | 1 |
| Vascular disorders | ||||
| Deep Vein Thrombosis | 0/121 (0%) | 0 | 1/124 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| DuoFix HA | Porocoat Porous Coated | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/121 (5%) | 7/124 (5.6%) | ||
| Blood and lymphatic system disorders | ||||
| Blood Loss Anemia | 6/121 (5%) | 6 | 7/124 (5.6%) | 7 |
Limitations/Caveats
The protocol called for 400 subjects to be followed for 5 years, but due to slow enrollment the study closed early. 245 subjects were enrolled & study endpoint was modified to 2 years. Enrollment closed on June 30, 2006; study closed on Jan 29, 2009.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Barry Sisson |
|---|---|
| Organization | DePuy Orthopaedics, Inc |
| Phone | 574-372-7156 |
| BSisson@its.jnj.com |
Responsible Party:
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00306917
Other Study ID Numbers:
- SPD
First Posted:
Mar 27, 2006
Last Update Posted:
Jul 19, 2022
Last Verified:
Jun 1, 2022