Mini Stem DEXA (Dual Energy X-ray Absorptiometry) (MISDexa)

February 20, 2020 updated by: Smith & Nephew, Inc.

Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

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.

Detailed Description

The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

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.
Observational

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.
20

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

  • Australia
      • Windsor, Australia, 3181
        • Malabar Orthopaedic Clinic

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The purpose of this investigation is to assess the bone growth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a total hip replacement.

Description

Inclusion Criteria:

  • Patient has hip disease that requires a total hip arthroplasty.
  • Patient is willing to consent to participate in the study.
  • Patient plans to be available for the study duration.
  • Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

Exclusion Criteria:

  • Patient known to have insufficient bone stock.
  • Patient has had major non-arthroscopic surgery to the study hip.
  • Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
  • Patient has a known sensitivity to materials in the device.

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

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
DEXA Analysis of BMD at Preoperative Visit
Time Frame: Preoperative
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Preoperative
DEXA Analysis of BMD at 3 Months
Time Frame: 3 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
3 Months
DEXA Analysis of BMD at 6 Months
Time Frame: 6 Months
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
6 Months
DEXA Analysis of BMD at 1 Year
Time Frame: 1 Year
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
1 Year
DEXA Analysis of BMD at 2 Years
Time Frame: 2 Year
DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
2 Year

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
Baseline Harris Hip Score (HHS) at Preoperative Visit
Time Frame: Preoperative

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Preoperative
Harris Hip Score (HHS) at 3 Month Visit
Time Frame: 3 Month

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
3 Month
Harris Hip Score (HHS) at 6 Month Visit
Time Frame: 6 Months

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
6 Months
Harris Hip Score (HHS) at 1 Year Visit
Time Frame: 1 Year

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
1 Year
Harris Hip Score (HHS) at 2 Year Visit
Time Frame: 2 Years

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
2 Years
Harris Hip Score (HHS) at 5 Year Visit
Time Frame: 5 Year

The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:

Total Scale Ranges:

Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60

Subscore Ranges:

Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5

The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
5 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Time Frame: Preoperative

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Preoperative
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Time Frame: 3 Months

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
3 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Time Frame: 6 Months

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
6 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Time Frame: 1 Year

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
1 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Time Frame: 2 Years

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
2 Years
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Time Frame: 5 Years

The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).

Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.

Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
5 Years
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Time Frame: Discharge

Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.

The Brooker Classification was defined as:

Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
Discharge
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Time Frame: 3 Months

Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.

The Brooker Classification was defined as:

Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
3 Months
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Time Frame: 1 Year

Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.

The Brooker Classification was defined as:

Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
1 Year
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Time Frame: 5 Year

Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.

The Brooker Classification was defined as:

Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
5 Year
Radiographic Assessment at Discharge Visit
Time Frame: Discharge
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Discharge
Radiographic Assessment at 3 Month Visit
Time Frame: 3 Months
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
3 Months
Radiographic Assessment at 1 Year Visit
Time Frame: 1 Year
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
1 Year
Radiographic Assessment at 5 Year Visit
Time Frame: 5 Year
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
5 Year
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Time Frame: Discharge
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Discharge
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Time Frame: 3 Months
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
3 Months
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Time Frame: 1 Year
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
1 Year
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Time Frame: 5 Years
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
5 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: Steve McMahon, MD, Malabar Orthopaedic Clinic
  • Study Chair: Beate Hanson, MD, PhD, Vice Presidient, Global Clinical Strategy

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.
September 14, 2009

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.
April 18, 2016

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.
April 18, 2016

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).
February 9, 2010

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.
February 9, 2010

First Posted (ESTIMATE)

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.
February 10, 2010

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.
March 6, 2020

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.
February 20, 2020

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.
February 1, 2020

More Information

Terms related to this study

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.
  • 2090SMFH131

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.

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