Trial Outcomes & Findings for Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement (NCT NCT00306917)

Last Updated: 2022-07-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

245 participants

Primary outcome timeframe

Preoperative, 6, 12, 24, 36, 48, and 60 months

Results posted on

2022-07-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	121	124
Overall Study Postoperative to 6 Month Follow up	93	100
Overall Study 12 Month Follow	86	94
Overall Study 24 Month Follow up	60	71
Overall Study 36 Month Follow up	56	42
Overall Study 48 Month Follow up	29	22
Overall Study 60 Month Follow up	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	108	109

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DuoFix HA n=121 Participants 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 n=124 Participants 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 n=245 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 8.2 • n=5 Participants	63.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	63.8 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	64 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	60 Participants n=7 Participants	114 Participants n=5 Participants
Region of Enrollment United States · United States	121 Participants n=5 Participants	124 Participants n=7 Participants	245 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperative, 6, 12, 24, 36, 48, and 60 months

Population: 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.

Outcome measures

Outcome measures
Measure	DuoFix HA n=121 Participants 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 n=124 Participants 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.
Harris Hip Score (HHS) Preoperative HHS	49.9 Units on a scale Standard Deviation 13.4	51.2 Units on a scale Standard Deviation 14.0
Harris Hip Score (HHS) Postoperative to 6 Month HHS	90.2 Units on a scale Standard Deviation 10.3	91.6 Units on a scale Standard Deviation 8.3
Harris Hip Score (HHS) 12 Month HHS	92.8 Units on a scale Standard Deviation 7.9	92.3 Units on a scale Standard Deviation 11.6
Harris Hip Score (HHS) 24 Month HHS	93.3 Units on a scale Standard Deviation 7.8	93.5 Units on a scale Standard Deviation 9.7
Harris Hip Score (HHS) 36 Month HHS	94.0 Units on a scale Standard Deviation 8.5	93.8 Units on a scale Standard Deviation 9.4
Harris Hip Score (HHS) 48 Month HHS	91.8 Units on a scale Standard Deviation 12.2	95.5 Units on a scale Standard Deviation 10.5
Harris Hip Score (HHS) 60 Month HHS	93.8 Units on a scale Standard Deviation 7.9	93.6 Units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	DuoFix HA n=121 Participants 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 n=124 Participants 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.
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Subsidence (10 mm)	1 Percentage of Participants Analyzed	0 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Osseointegration	82 Percentage of Participants Analyzed	80 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Radiolucency > 2 mm in any zone	0 Percentage of Participants Analyzed	0 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Complete Circumferential Radiolucencies	0 Percentage of Participants Analyzed	0 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Spot-Welds (AP View) p < .10	23 Percentage of Participants Analyzed	14 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Spot-Welds (Lateral View) p < .10	8 Percentage of Participants Analyzed	3 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Cortical Hypertrophy (AP View)	12 Percentage of Participants Analyzed	12 Percentage of Participants Analyzed
Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Cortical Hypertrophy (Lateral View)	3 Percentage of Participants Analyzed	4 Percentage of Participants Analyzed

Adverse Events

DuoFix HA

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Porocoat Porous Coated

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DuoFix HA n=121 participants at risk 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 n=124 participants at risk 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.
Cardiac disorders Cardiovascular Arrhythmia	0.00% 0/121	0.81% 1/124 • Number of events 1
Vascular disorders Deep Vein Thrombosis	0.00% 0/121	0.81% 1/124 • Number of events 1
Musculoskeletal and connective tissue disorders Dislocation	0.83% 1/121 • Number of events 2	0.00% 0/124
Skin and subcutaneous tissue disorders Hematoma	0.00% 0/121	0.81% 1/124 • Number of events 1
Infections and infestations Infection: Deep	0.83% 1/121 • Number of events 1	0.81% 1/124 • Number of events 1
Skin and subcutaneous tissue disorders Infection: Superficial	0.00% 0/121	0.81% 1/124 • Number of events 1
Musculoskeletal and connective tissue disorders Liner failure: dislocation	0.83% 1/121 • Number of events 1	0.00% 0/124

Other adverse events

Other adverse events
Measure	DuoFix HA n=121 participants at risk 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 n=124 participants at risk 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.
Blood and lymphatic system disorders Blood Loss Anemia	5.0% 6/121 • Number of events 6	5.6% 7/124 • Number of events 7

Additional Information

Barry Sisson

DePuy Orthopaedics, Inc

Phone: 574-372-7156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60