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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status

Completed

Phase

Phase 4

Locations

Slovakia

Study Type

Interventional

Intervention

SmartSet® HV bone cement

SmartSet® GHV bone cement

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Bone Cement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orthopaedic-traumatology Clinic University Hospital Martin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1) SmartSet® HV Bone Cement

2) SmartSet® GHV Bone Cement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship

Secondary Outcome Measures

Harris Hip Score

Oxford Hip Score

Radiological Analysis

Full Information

NCT ID

NCT00872066

First Posted

March 19, 2009

Last Updated

March 2, 2017

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00872066

Brief Title

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

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1) SmartSet® HV Bone Cement

Arm Type

Active Comparator

Arm Description

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

Arm Title

2) SmartSet® GHV Bone Cement

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

SmartSet® HV bone cement

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SmartSet® GHV bone cement

Intervention Description

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

Primary Outcome Measure Information:

Title

Kaplan-Meier survivorship

Time Frame

Annually

Secondary Outcome Measure Information:

Title

Harris Hip Score

Time Frame

Annually

Title

Oxford Hip Score

Time Frame

Annually

Title

Radiological Analysis

Time Frame

Annually

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Libor Nečas, M.D.

Organizational Affiliation

Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthopaedic-traumatology Clinic University Hospital Martin

City

Martin

Country

Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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