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Completed

NCT Number: NCT01066936

Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Malabar Orthopaedic Clinic

Windsor, 3181, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. Radiographic Assessment at Discharge Visit

    Time frame: Discharge

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  18. Radiographic Assessment at 3 Month Visit

    Time frame: 3 Months

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  19. Radiographic Assessment at 1 Year Visit

    Time frame: 1 Year

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  20. Radiographic Assessment at 5 Year Visit

    Time frame: 5 Year

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Acronym: MISDexa

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2010
Registry last updated
Mar 6, 2020

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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