Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001062213
Ethics application status
Approved
Date submitted
7/12/2009
Date registered
10/12/2009
Date last updated
30/10/2023
Date data sharing statement initially provided
30/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty with the "Short Mini Stem"
Scientific title
A Prospective, single center, consecutive series with 5 years follow up of 20 patients with non inflammatory arthritis analyzing bone remodelling using DEXA after total Hip Arthroplasty using the Smith and Nephew "Short Mini Stem".
Secondary ID [1] 1187 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Joint disease 252352 0
Condition category
Condition code
Musculoskeletal 252541 252541 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total Hip Arthroplasty - The "Short Mini Stem" is a total hip replacement system consisting of lightweight titanium alloy inserted using a minimally invasive surgical (MIS) approach. The "Short Mini Stem" is shorter than conventional hip stems, which allows the stem to conserve more of the patient's thigh bone (femur) than other prostheses and requires a smaller skin incision. The approximate duration of the hip arthroplasty procedure is one hour.
Intervention code [1] 255662 0
Treatment: Devices
Intervention code [2] 255676 0
Treatment: Surgery
Comparator / control treatment
Five year longitudinal study by W.Brodner et al. "Changes in bone mineral density in the proximal femur after cementless total hip arthroplasty" JBJS (Br) 2004;86-B:20-6
Control group
Historical

Outcomes
Primary outcome [1] 253423 0
Assess the Bone ingrowth by DEXA and radiographs following implantation
Timepoint [1] 253423 0
pre-operative, 3 months, 6 months, 12 months, 2 years, 5 years
Secondary outcome [1] 262534 0
Patient Quality of Life questionnaires
Timepoint [1] 262534 0
pre-operative, 3 months, 12 months, 2 years, 3 years, 5 years
Secondary outcome [2] 262535 0
Clinical/Functional Evauation including range of motion using the Harris Hip Score (HHS) and Hip Osteoarthritis Outcome Score (HOOS).
Timepoint [2] 262535 0
pre-operative, 3 months, 12 months, 2 years, 3 years, 5 years

Eligibility
Key inclusion criteria
1. Patient has hip disease that requires a total hip arthroplasty
2. Patient is willing to consent to participate in the study
3. Patient plans to be available for the study duration
4. Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, haematological, 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
1. Patient known to have insufficient bone stock
2. Patient has had major non-arthroscopic surgery to the study hip
3. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up
4. patient has a known sensitivity to materials in the device

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective, consecutive series, single center clinical study of clinical outcomes following total hip arthroplasty. Patients meeting the entrance criteria specified in this protocol will be enrolled sequentially as they become available.

Process:
All patients requiring a Total Hip replacement were approached to participate in the MIS DEXA study during their pre-operative consultation. The PI discussed the clinical study and provided them with a copy of the HREC approved information sheet and consent. All patients were given the opportunity to ask questions during this discussion and in a further discussion with the study coordinator.

Patients that were interested in participating in the study, but did not want to sign the consent form on the same day, took the information sheets and consent forms home to review and were told to ring the study coordinator if they had any further questions.

Patients and their witness signed and dated the form and then posted the original consent form back to the study coordinator at the site. Patients kept the information sheet for reference.

On delivery to the site the forms were filed in the patient study file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
14/09/2009
Date of last participant enrolment
Anticipated
Actual
18/05/2010
Date of last data collection
Anticipated
Actual
18/04/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 256141 0
Commercial sector/Industry
Name [1] 256141 0
Smith and Nephew Inc.
Country [1] 256141 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Smith and Nephew Surgical (local sponsor)
Address
85 Waterloo Road
North Ryde 2113 NSW
Country
Australia
Secondary sponsor category [1] 251482 0
None
Name [1] 251482 0
Address [1] 251482 0
Country [1] 251482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258234 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 258234 0
Ethics committee country [1] 258234 0
Australia
Date submitted for ethics approval [1] 258234 0
Approval date [1] 258234 0
30/10/2008
Ethics approval number [1] 258234 0
01-15-12-08

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30590 0
Mr Stephen McMahon
Address 30590 0
Malabar Orthopaedic Clinic 43 The Avenue Windsor Vic 3181
Country 30590 0
Australia
Phone 30590 0
+61 3 9510 7766
Fax 30590 0
Email 30590 0
[email protected]
Contact person for public queries
Name 13837 0
Andrew Copley
Address 13837 0
Smith & Nephew Pty Ltd, Suite 1.01, Level 1, Building 1, Pinnacle Office Park, 4 Drake Avenue, Macquarie Park NSW 2113
Country 13837 0
Australia
Phone 13837 0
+61 2 9857 3999
Fax 13837 0
Email 13837 0
[email protected]
Contact person for scientific queries
Name 4765 0
Dr Gabrielle Hawdon
Address 4765 0
Malabar Orthopaedic Clinic
43 The Avenue
Windsor Vic 3181
Country 4765 0
Australia
Phone 4765 0
+61 3 9510 7766
Fax 4765 0
+61 3 9507 5590
Email 4765 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20790Study protocol  [email protected]
20791Informed consent form  [email protected]
20792Ethical approval  [email protected]
20793Clinical study report  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.