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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01066936




Registration number
NCT01066936
Ethics application status
Date submitted
9/02/2010
Date registered
10/02/2010
Date last updated
6/03/2020

Titles & IDs
Public title
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Scientific title
Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
Secondary ID [1] 0 0
2090SMFH131
Universal Trial Number (UTN)
Trial acronym
MISDexa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DEXA Analysis of BMD at Preoperative Visit
Timepoint [1] 0 0
Preoperative
Primary outcome [2] 0 0
DEXA Analysis of BMD at 3 Months
Timepoint [2] 0 0
3 Months
Primary outcome [3] 0 0
DEXA Analysis of BMD at 6 Months
Timepoint [3] 0 0
6 Months
Primary outcome [4] 0 0
DEXA Analysis of BMD at 1 Year
Timepoint [4] 0 0
1 Year
Primary outcome [5] 0 0
DEXA Analysis of BMD at 2 Years
Timepoint [5] 0 0
2 Year
Secondary outcome [1] 0 0
Baseline Harris Hip Score (HHS) at Preoperative Visit
Timepoint [1] 0 0
Preoperative
Secondary outcome [2] 0 0
Harris Hip Score (HHS) at 3 Month Visit
Timepoint [2] 0 0
3 Month
Secondary outcome [3] 0 0
Harris Hip Score (HHS) at 6 Month Visit
Timepoint [3] 0 0
6 Months
Secondary outcome [4] 0 0
Harris Hip Score (HHS) at 1 Year Visit
Timepoint [4] 0 0
1 Year
Secondary outcome [5] 0 0
Harris Hip Score (HHS) at 2 Year Visit
Timepoint [5] 0 0
2 Years
Secondary outcome [6] 0 0
Harris Hip Score (HHS) at 5 Year Visit
Timepoint [6] 0 0
5 Year
Secondary outcome [7] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Timepoint [7] 0 0
Preoperative
Secondary outcome [8] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Timepoint [8] 0 0
3 Months
Secondary outcome [9] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Timepoint [9] 0 0
6 Months
Secondary outcome [10] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Timepoint [10] 0 0
1 Year
Secondary outcome [11] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Timepoint [11] 0 0
2 Years
Secondary outcome [12] 0 0
Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Timepoint [12] 0 0
5 Years
Secondary outcome [13] 0 0
Radiographic Assessment at Preoperative Visit (Yes/No Components)
Timepoint [13] 0 0
Discharge
Secondary outcome [14] 0 0
Radiographic Assessment at 3 Month Visit (Yes/No Components)
Timepoint [14] 0 0
3 Months
Secondary outcome [15] 0 0
Radiographic Assessment at 1 Year Visit (Yes/No Components)
Timepoint [15] 0 0
1 Year
Secondary outcome [16] 0 0
Radiographic Assessment at 5 Year Visit (Yes/No Components)
Timepoint [16] 0 0
5 Year
Secondary outcome [17] 0 0
Radiographic Assessment at Discharge Visit
Timepoint [17] 0 0
Discharge
Secondary outcome [18] 0 0
Radiographic Assessment at 3 Month Visit
Timepoint [18] 0 0
3 Months
Secondary outcome [19] 0 0
Radiographic Assessment at 1 Year Visit
Timepoint [19] 0 0
1 Year
Secondary outcome [20] 0 0
Radiographic Assessment at 5 Year Visit
Timepoint [20] 0 0
5 Year
Secondary outcome [21] 0 0
Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Timepoint [21] 0 0
Discharge
Secondary outcome [22] 0 0
Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Timepoint [22] 0 0
3 Months
Secondary outcome [23] 0 0
Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Timepoint [23] 0 0
1 Year
Secondary outcome [24] 0 0
Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Timepoint [24] 0 0
5 Years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/04/2016
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Malabar Orthopaedic Clinic - Windsor
Recruitment postcode(s) [1] 0 0
3181 - Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01066936
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steve McMahon, MD
Address 0 0
Malabar Orthopaedic Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01066936