Clinical trial NCT01066936: Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Official title: Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DEXA Analysis of BMD at Preoperative Visit
timeFrame: Preoperative
measure: DEXA Analysis of BMD at 3 Months
timeFrame: 3 Months
measure: DEXA Analysis of BMD at 6 Months
timeFrame: 6 Months
measure: DEXA Analysis of BMD at 1 Year
timeFrame: 1 Year
measure: DEXA Analysis of BMD at 2 Years
timeFrame: 2 Year
Secondary outcomes:
measure: Baseline Harris Hip Score (HHS) at Preoperative Visit
timeFrame: Preoperative
measure: Harris Hip Score (HHS) at 3 Month Visit
timeFrame: 3 Month
measure: Harris Hip Score (HHS) at 6 Month Visit
timeFrame: 6 Months
measure: Harris Hip Score (HHS) at 1 Year Visit
timeFrame: 1 Year
measure: Harris Hip Score (HHS) at 2 Year Visit
timeFrame: 2 Years
measure: Harris Hip Score (HHS) at 5 Year Visit
timeFrame: 5 Year
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
timeFrame: Preoperative
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
timeFrame: 3 Months
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
timeFrame: 6 Months
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
timeFrame: 1 Year
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
timeFrame: 2 Years
measure: Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
timeFrame: 5 Years
measure: Radiographic Assessment at Preoperative Visit (Yes/No Components)
timeFrame: Discharge
measure: Radiographic Assessment at 3 Month Visit (Yes/No Components)
timeFrame: 3 Months
measure: Radiographic Assessment at 1 Year Visit (Yes/No Components)
timeFrame: 1 Year
measure: Radiographic Assessment at 5 Year Visit (Yes/No Components)
timeFrame: 5 Year
measure: Radiographic Assessment at Discharge Visit
timeFrame: Discharge
measure: Radiographic Assessment at 3 Month Visit
timeFrame: 3 Months
measure: Radiographic Assessment at 1 Year Visit
timeFrame: 1 Year
measure: Radiographic Assessment at 5 Year Visit
timeFrame: 5 Year
measure: Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
timeFrame: Discharge
measure: Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
timeFrame: 3 Months
measure: Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
timeFrame: 1 Year
measure: Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
timeFrame: 5 Years
Other outcomes:
Locations:
city: Windsor
country: Australia
facility: Malabar Orthopaedic Clinic
Study officials:
affiliation: Malabar Orthopaedic Clinic
name: Steve McMahon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vice Presidient, Global Clinical Strategy
name: Beate Hanson, MD, PhD
role: STUDY_CHAIR
References: