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Completed

NCT Number: NCT00872066

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Bone Diseases, Developmental Collagen Diseases Collagen Disorders Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Developmental Dysplasia of the Hip Epiphyses, Slipped Hip Dislocation, Congenital Immune System Diseases Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Nonunion of Femoral Fractures Osteoarthritis Osteochondrodysplasias Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Arthritis Rheumatic Diseases Skin and Connective Tissue Diseases Slipped Capital Femoral Epiphyses Slipped Capital Femoral Epiphysis Traumatic Femoral Fractures

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopaedic-traumatology Clinic University Hospital Martin

Martin, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

SmartSet® HV bone cement

Device

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

SmartSet® GHV bone cement

Device

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

Primary outcomes

  1. Kaplan-Meier survivorship

    Time frame: Annually

Secondary outcomes

  1. Harris Hip Score

    Time frame: Annually

  2. Oxford Hip Score

    Time frame: Annually

  3. Radiological Analysis

    Time frame: Annually

Sponsors and collaborators

Lead sponsor

DePuy International

Industry

Registry information

Official study title

A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2009
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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