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

Rheumatoid Arthritis Clinical Trial

— SPD  

Official title:

A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00306917
• Other study ID #: SPD
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2002
• Est. completion date: January 29, 2009

Study information

• Verified date: June 2022
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 245
• Est. completion date: January 29, 2009
• Est. primary completion date: January 29, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Fracture
• Arthritis
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Intervention

Device:
• non-coated femoral hip stem
total hip replacement
• coated femoral hip stem
total hip replacement

Locations

Country	Name	City	State
United States	DePuy Orthopaedics	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score (HHS)	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, 6, 12, 24, 36, 48, and 60 months
Secondary	Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.	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)	Postoperative, 6, 12, 24, 36, 48 and 60 months