A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement

NCT00872066 | Completed Phase 4

• 1 other identifier: CT02/11
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments

Conditions

Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Keywords

Hip; Bone Cement

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship

  Annually

Secondary Outcomes (3)

• Harris Hip Score

  Annually

• Oxford Hip Score

  Annually

• Radiological Analysis

  Annually

Study Arms (2)

1) SmartSet® HV Bone Cement

ACTIVE COMPARATOR

A high viscosity bone cement for use in total hip replacement (without gentamicin)

Device: SmartSet® HV bone cement

2) SmartSet® GHV Bone Cement

ACTIVE COMPARATOR

A high viscosity bone cement for use in total hip replacement (with gentamicin)

Device: SmartSet® GHV bone cement

Interventions

SmartSet® HV bone cement DEVICE

A high viscosity bone cement for use in total hip replacement (without gentamicin)

1) SmartSet® HV Bone Cement

SmartSet® GHV bone cement DEVICE

A high viscosity bone cement for use in total hip replacement (with gentamicin)

2) SmartSet® GHV Bone Cement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) Male or female subjects, aged between 18 and 75 years (inclusive).
• ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
• iv) Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

You may not qualify if:

• i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• ii) Women who are pregnant.
• iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
• iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
• v) Subjects who are currently involved in any injury litigation claims.
• vi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Orthopaedic-traumatology Clinic University Hospital Martin

Martin, Slovakia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Officials

• Libor Nečas, M.D.

  Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 31, 2009
• Study Start: March 1, 2006
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

SL (1)