NCT00306917: SPD

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

Terminated NA Results posted Last updated 19 July 2022

What this trial tests

NA trial testing non-coated femoral hip stem in Osteoarthritis in 245 participants. Terminated before completion.

Timeline

1 November 2002

Primary endpoint
29 January 2009

29 January 2009

Quick facts

Lead sponsor	DePuy Orthopaedics
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	245
Start date	1 November 2002
Primary completion	29 January 2009
Estimated completion	29 January 2009
Sites	1 location across United States

Drugs / interventions tested

• non-coated femoral hip stem
• coated femoral hip stem

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Post-traumatic Arthritis — all drugs for Post-traumatic Arthritis →
• Avascular Necrosis — all drugs for Avascular Necrosis →

Sponsor

DePuy Orthopaedics — full company profile →

Who can join

Under 75, any sex, with Osteoarthritis or Rheumatoid Arthritis. 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.

Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure. Secondary · 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), Corti

Subsidence (10 mm)

Group	Value	95% CI
DuoFix HA	1
Porocoat Porous Coated	0

Osseointegration

Group	Value	95% CI
DuoFix HA	82
Porocoat Porous Coated	80

Radiolucency > 2 mm in any zone

Group	Value	95% CI
DuoFix HA	0
Porocoat Porous Coated	0

Complete Circumferential Radiolucencies

Group	Value	95% CI
DuoFix HA	0
Porocoat Porous Coated	0

Spot-Welds (AP View) p < .10

Group	Value	95% CI
DuoFix HA	23
Porocoat Porous Coated	14

Spot-Welds (Lateral View) p < .10

Group	Value	95% CI
DuoFix HA	8
Porocoat Porous Coated	3

Cortical Hypertrophy (AP View)

Group	Value	95% CI
DuoFix HA	12
Porocoat Porous Coated	12

Cortical Hypertrophy (Lateral View)

Group	Value	95% CI
DuoFix HA	3
Porocoat Porous Coated	4

Harris Hip Score (HHS) Primary · 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.

Preoperative HHS

Group	Value	95% CI
DuoFix HA	49.9	± 13.4
Porocoat Porous Coated	51.2	± 14.0

Postoperative to 6 Month HHS

Group	Value	95% CI
DuoFix HA	90.2	± 10.3
Porocoat Porous Coated	91.6	± 8.3

12 Month HHS

Group	Value	95% CI
DuoFix HA	92.8	± 7.9
Porocoat Porous Coated	92.3	± 11.6

24 Month HHS

Group	Value	95% CI
DuoFix HA	93.3	± 7.8
Porocoat Porous Coated	93.5	± 9.7

36 Month HHS

Group	Value	95% CI
DuoFix HA	94.0	± 8.5
Porocoat Porous Coated	93.8	± 9.4

48 Month HHS

Group	Value	95% CI
DuoFix HA	91.8	± 12.2
Porocoat Porous Coated	95.5	± 10.5

60 Month HHS

Group	Value	95% CI
DuoFix HA	93.8	± 7.9
Porocoat Porous Coated	93.6	± 7.8

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DuoFix HA

Serious: 3/121 (2%)

Deaths: —

Porocoat Porous Coated

Serious: 4/124 (3%)

Deaths: —

Serious adverse events (7 terms)

Reaction	System	DuoFix HA	Porocoat Porous Coated
Cardiovascular Arrhythmia	Cardiac disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—
Dislocation	Musculoskeletal and connective tissue disorders	—	—
Hematoma	Skin and subcutaneous tissue disorders	—	—
Infection: Deep	Infections and infestations	—	—
Infection: Superficial	Skin and subcutaneous tissue disorders	—	—
Liner failure: dislocation	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	DuoFix HA	Porocoat Porous Coated
Blood Loss Anemia	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Cardiovascular Arrhythmia, Deep Vein Thrombosis, Dislocation, Hematoma, Infection: Deep, Infection: Superficial, Liner failure: dislocation.

Data from ClinicalTrials.gov NCT00306917 adverse events section.

Sponsor's own description

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Publications & conference data

No peer-reviewed publications indexed yet for this trial.