Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000855022
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
14/10/2010
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study looking at whether or not a knee replacement moves inside the bone that it is inserted into and if it does move, this movement will be measured using x-rays.
Scientific title
Patients with non-inflammatory osteoarthritis requiring a partial knee replacement will have tantalum beads inserted at the time of surgery in order to reference implant movement over time and these results will be compared with results from the literature of others with partial knee replacements.
Secondary ID [1] 252744 0
Nil
Universal Trial Number (UTN)
U1111-1117-1897
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory osteoarthritis of the knee 258248 0
Condition category
Condition code
Musculoskeletal 258423 258423 0 0
Osteoarthritis
Surgery 258553 258553 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Partial knee replacement with the addition of between 5 and 9 Tantalum beads (metal beads 1mm in diameter) will be inserted into each of the proximal tibial and distal femoral bones. These beads define rigid bodies in order to reference the implants to for measurement purposes. The amount of time taken to insert the beads will be approximately 5 minutes longer than standard knee replacement surgery. The number of beads inserted is determined by the need to be able to clearly identify them and increase measurement accuracy. The majority of patients will have 5 beads inserted.
Intervention code [1] 257261 0
Treatment: Devices
Intervention code [2] 257365 0
Treatment: Surgery
Comparator / control treatment
Historical. The participant results will be compared with unicompartmental tibial component roenten stereophotogrammetric analysis (RSA) studies published in the literature from 2005 - 2010.
Control group
Historical

Outcomes
Primary outcome [1] 259272 0
Examine the amount of three-dimensional (3D) micromotion of a metal backed unicompartmental tibial component using a computer aided design (CAD) model based RSA (Group1) and then compare the results with unicompartmental tibial component RSA studies published in the literature (Group 2)
Timepoint [1] 259272 0
Each patient will be evaluated pre-operatively and then at 1 week, 4 months, 1 year and 2 years post-operatively
Secondary outcome [1] 265680 0
Nil
Timepoint [1] 265680 0
Nil

Eligibility
Key inclusion criteria
1. Consent
2. Non-inflammatory osteoarthritis of the medial
compartment of the knee
3. A mechanical axis deformity less than 10degrees varus
or 5 degrees valgus
4. An intact anterior cruciate ligament without medial-lateral
subluxation
5. A flexion contracture less than 10degrees
6. Body weight less than 90kg
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with active infection
2. Patients requiring total knee replacement surgery
3. Patients requiring revision surgery of a previously implanted unicompartmental knee
4. Patients with presence of malignancy in the area of the involved knee joint
5. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule
6. Patients with a physical condition (ie. weight exceeding 90kgs) or a neuromuscular deficit which interferes with the patient's ability to limit weight-bearing or places an extreme load on the implant during the healing period
7. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis

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)
Patients will be selected and enrolled by the Prinicipal Investigator at his department/practice. The Investigator will inform the patient of the purpose of the study, the proposed duration of the study and the follow-up schedule. All forseeable risks involved, as well as potential benefits that result from the joint reconstruction will also be explained. If the patient agrees to join the study, they will be enrolled and given a copy of the Patient Information Sheet for their records.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a registration study and participants are not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
27/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257705 0
Commercial sector/Industry
Name [1] 257705 0
De Puy International
Country [1] 257705 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
De Puy International
Address
St Anthony's Road
LEEDS LS11 8DT
Country
United Kingdom
Secondary sponsor category [1] 256921 0
None
Name [1] 256921 0
Address [1] 256921 0
Country [1] 256921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259738 0
John Flynn Human Research Ethics Committee
Ethics committee address [1] 259738 0
Ethics committee country [1] 259738 0
Australia
Date submitted for ethics approval [1] 259738 0
14/08/2009
Approval date [1] 259738 0
19/01/2010
Ethics approval number [1] 259738 0
9/04/2010

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

Contacts
Principal investigator
Name 31681 0
Dr Ray Randle
Address 31681 0
John Flynn Medical Centre
42 Inland Drive,
Tugun QLD 4224
Country 31681 0
Australia
Phone 31681 0
+61 (0) 7 5598 0094
Fax 31681 0
Email 31681 0
[email protected]
Contact person for public queries
Name 14928 0
Mark Gillies
Address 14928 0
149 Edgeware Road
ENMORE NSW 2042
Country 14928 0
Australia
Phone 14928 0
+61 (0)413 309 972
Fax 14928 0
Nil
Email 14928 0
[email protected]
Contact person for scientific queries
Name 5856 0
Mark Gillies
Address 5856 0
149 Edgeware Road
ENMORE NSW 2042
Country 5856 0
Australia
Phone 5856 0
+61 (0)413 309 972
Fax 5856 0
Nil
Email 5856 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
This study did not go ahead


What supporting documents are/will be available?

No Supporting Document Provided



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.