Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

October 18, 2024 updated by: Smith & Nephew, Inc.

A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group

The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa, 4001
        • Entabeni Hospital
      • Pretoria, South Africa, 0002
        • Zuid Afrikaans Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 21 years old
  • Skeletally mature
  • Requires primary, unilateral total hip arthroplasty due to degenerative join disease
  • Preoperative Harris Hip Score of less than or equal to 70
  • Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
  • Given consent to participate in the study

  • Able to understand the purpose of the study, his/her role, and is available for follow-up

    10 year extension:

    • Subject has completed the 2 year primary study
    • Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
    • Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion Criteria:

  • Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
  • Requires bilateral THA
  • Requires revision of a prior hip replacement
  • Active infection or sepsis
  • History of local hip infection
  • Known metastatic or neoplastic disease
  • Conditions that may interfere with THA survival or outcomes
  • Need for structural bone grafts to support the implant
  • Contralateral lower extremity condition
  • Has other joint replacements or plans for other joint replacements within 2 years
  • Systemic steroid therapy within 3 months prior to surgery
  • Life expectancy less than 2 years
  • Intra-articular therapy within 6 months of enrollment
  • Female of child-bearing age not using contraception
  • Inadequate bone stock to support the device
  • Moderate to severe renal insufficiency
  • Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
  • BMI >40
  • Above the knee amputation of the contralateral or ipsilateral leg
  • Known allergies to the components of the devices
  • Entered into another investigational study

  • Is a prisoner

    10 year extension:

    • In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Total Hip Replacement Device

Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:

  • R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
  • OXINIUM heads on polyethylene liners or
  • Ceramic heads on ceramic liners (all uncemented components)
Device: ODH Hip System
Other Names:
  • Total Hip Replacement
  • Total Hip Arthroplasty
  • THA
  • THR
Experimental: Investigational Hard-on-Hard Total Hip Replacement Device

Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:

  • R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
  • R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
  • R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
  • Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
Device: ODH Hip System
Other Names:
  • Total Hip Replacement
  • Total Hip Arthroplasty
  • THA
  • THR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Device-Related Revisions
Time Frame: Postoperatively through 10 years
Device related revisions reported by the number of participants with a revision required (Yes/No).
Postoperatively through 10 years
Metal Ion Concentration in Whole Blood
Time Frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.
3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
Time Frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.
Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
Time Frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years
The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.
Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years
Radiographic Measures: Radiolucencies
Time Frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)
3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Heterotopic Ossification
Time Frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Occurrence of Heterotopic Ossification in participants (Yes/No)
3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Subsidence
Time Frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative

Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by:

  • Acetabular Cup Subsidence
  • Stem Subsidence
  • Evidence of cortical thickening
  • Acetabular component fail
  • Femoral component fail
  • Other
3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Health Economic Outcomes: Surgical Blood Loss
Time Frame: Intra-operative, up to 50 minutes
Blood loss during surgery measured in milliliters (ml) of blood
Intra-operative, up to 50 minutes
Health Economic Outcomes: Length of Hospital Stay
Time Frame: Hospital admission to discharge
Length of stay measured by number of days spent in hospital
Hospital admission to discharge
Health Economic Outcomes: Operative Time
Time Frame: Intra-operative
Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only
Intra-operative
Health Economic Outcomes: Re-Hospitalizations
Time Frame: Up to 10 years
Re-hospitalizations measured by the number of re-admissions to hospital
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Baker, Entabeni Hospital
  • Principal Investigator: Johannes de Beer, Zuid Afrikaans Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-ODHH166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Degenerative

Clinical Trials on ODH Hip System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings