Osteoarthritis, HipMISDexaNCT01066936

Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

An observational study of Osteoarthritis, Hip, run by Smith & Nephew, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteoarthritis, Hip
How many people: 20 participants
Where: 1 siteAustralia
Study dates: 14 Sep 2009to 18 Apr 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Malabar Orthopaedic Clinic
Windsor, 3181

Other trials in Australia

About this study

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

Read the 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.

Conditions: Osteoarthritis, Hip
Medical subject headings: Osteoarthritis, Hip

What is being measured

The primary outcome is the main question the study is designed to answer.

DEXA Analysis of BMD at Preoperative Visit
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.
Measured: Preoperative
DEXA Analysis of BMD at 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.
Measured: 3 Months
DEXA Analysis of BMD at 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.
Measured: 6 Months
DEXA Analysis of BMD at 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.
Measured: 1 Year
DEXA Analysis of BMD at 2 Years
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.
Measured: 2 Year

Secondary outcomes (24)

Baseline Harris Hip Score (HHS) at Preoperative Visit
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.
Measured: Preoperative
Harris Hip Score (HHS) at 3 Month Visit
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.
Measured: 3 Month
Harris Hip Score (HHS) at 6 Month Visit
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.
Measured: 6 Months
Harris Hip Score (HHS) at 1 Year Visit
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.
Measured: 1 Year
Harris Hip Score (HHS) at 2 Year Visit
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.
Measured: 2 Years
Harris Hip Score (HHS) at 5 Year Visit
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.
Measured: 5 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
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.
Measured: Preoperative
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
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.
Measured: 3 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
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.
Measured: 6 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
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.
Measured: 1 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
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.
Measured: 2 Years
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
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.
Measured: 5 Years
Radiographic Assessment at Preoperative Visit (Yes/No Components)
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
Measured: Discharge
Radiographic Assessment at 3 Month Visit (Yes/No Components)
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
Measured: 3 Months
Radiographic Assessment at 1 Year Visit (Yes/No Components)
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
Measured: 1 Year
Radiographic Assessment at 5 Year Visit (Yes/No Components)
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
Measured: 5 Year
Radiographic Assessment at Discharge Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: Discharge
Radiographic Assessment at 3 Month Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 3 Months
Radiographic Assessment at 1 Year Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 1 Year
Radiographic Assessment at 5 Year Visit
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 5 Year
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: Discharge
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 3 Months
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 1 Year
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 200918 Apr 2016

First posted10 Feb 2010 (estimated)
Study start14 Sep 2009
Primary completion18 Apr 2016
Study completion18 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01066936
Sponsor's protocol ID: 2090SMFH131
Acronym: MISDexa
Status last verified: Feb 2020
First submitted: 9 Feb 2010
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
ClinicalTrials.gov ID: NCT01066936
Acronym / sponsor ID: MISDexa / 2090SMFH131
Conditions: Osteoarthritis, Hip
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 14 Sep 2009 (actual)
Primary completion: 18 Apr 2016 (actual)
Study completion: 18 Apr 2016 (actual)
First posted: 10 Feb 2010 (estimated)
Results: Posted 6 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.
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.

24 secondary outcomes

Baseline Harris Hip Score (HHS) at Preoperative Visit
Time frame: Preoperative
Harris Hip Score (HHS) at 3 Month Visit
Time frame: 3 Month
Harris Hip Score (HHS) at 6 Month Visit
Time frame: 6 Months
Harris Hip Score (HHS) at 1 Year Visit
Time frame: 1 Year
Harris Hip Score (HHS) at 2 Year Visit
Time frame: 2 Years
Harris Hip Score (HHS) at 5 Year Visit
Time frame: 5 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Time frame: Preoperative
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Time frame: 3 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Time frame: 6 Months
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Time frame: 1 Year
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Time frame: 2 Years
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Time frame: 5 Years
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Time frame: Discharge
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Time frame: 3 Months
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Time frame: 1 Year
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Time frame: 5 Year
Radiographic Assessment at Discharge Visit
Time frame: Discharge
Radiographic Assessment at 3 Month Visit
Time frame: 3 Months
Radiographic Assessment at 1 Year Visit
Time frame: 1 Year
Radiographic Assessment at 5 Year Visit
Time frame: 5 Year
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Time frame: Discharge
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Time frame: 3 Months
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Time frame: 1 Year
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Time frame: 5 Years

Results and safety

Results posted to the registry on 6 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MIS (Mini Stem) Stem	20	10

Primary outcome: DEXA Analysis of BMD at Preoperative Visit

Time frame: Preoperative. Mean (Standard Deviation). Unit: g/cm^2

Measure	MIS Stem n = 20
Femoral Region 1	0.8 (0.22)
Femoral Region 2	1.0 (0.25)
Femoral Region 3	1.6 (0.31)
Femoral Region 4	2.0 (0.32)
Femoral Region 5	1.8 (0.33)
Femoral Region 6	1.3 (0.29)
Femoral Region 7	1.4 (0.31)

Primary outcome: DEXA Analysis of BMD at 3 Months

Time frame: 3 Months. Mean (Standard Deviation). Unit: g/cm^2

Measure	Study Population n = 20
Femoral Region 1	0.8 (0.18)
Femoral Region 2	1.3 (0.26)
Femoral Region 3	2.1 (0.39)
Femoral Region 4	1.9 (0.27)
Femoral Region 5	1.9 (0.27)
Femoral Region 6	1.5 (0.32)
Femoral Region 7	1.3 (0.27)

Primary outcome: DEXA Analysis of BMD at 6 Months

Time frame: 6 Months. Mean (Standard Deviation). Unit: g/cm^2

Measure	Study Population n = 20
Femoral Region 1	0.8 (0.19)
Femoral Region 2	1.3 (0.31)
Femoral Region 3	2.1 (0.38)
Femoral Region 4	1.9 (0.30)
Femoral Region 5	2.0 (0.28)
Femoral Region 6	1.6 (0.30)
Femoral Region 7	1.2 (0.35)

Primary outcome: DEXA Analysis of BMD at 1 Year

Time frame: 1 Year. Mean (Standard Deviation). Unit: g/cm^2

Measure	Study Population n = 20
Femoral Region 1	0.8 (0.20)
Femoral Region 2	1.3 (0.29)
Femoral Region 3	2.1 (0.41)
Femoral Region 4	1.9 (0.30)
Femoral Region 5	1.9 (0.31)
Femoral Region 6	1.6 (0.37)
Femoral Region 7	1.3 (0.30)

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIS Stem	13 of 20 (65%)	14 of 20 (70%)	2 of 20

Limitations and caveats (from the sponsor): There was a decreased compliance rate at the 3 year follow-up and a 50% termination rate by the 5 year follow-up resulting in a much smaller sample sizes for data collection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve McMahon, MD principal investigator

Malabar Orthopaedic Clinic

Beate Hanson, MD, PhD study chair

Vice Presidient, Global Clinical Strategy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Hip, run by Smith & Nephew, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DEXA Analysis of BMD at Preoperative Visit (time frame: Preoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01066936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.