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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00734084




Registration number
NCT00734084
Ethics application status
Date submitted
11/08/2008
Date registered
13/08/2008
Date last updated
9/06/2015

Titles & IDs
Public title
A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee
Scientific title
A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.
Secondary ID [1] 0 0
CT 01/34
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Preservation Unicompartmental Knee

Other: Preservation Unicompartmental Knee - Minimally invasive orthopaedic implant for single compartment knee arthritis


Treatment: Devices: Preservation Unicompartmental Knee
Minimally invasive orthopaedic implant for single compartment knee arthritis
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
Timepoint [1] 0 0
0 days
Secondary outcome [1] 0 0
To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis.
Timepoint [1] 0 0
6 months, 1, 3, 5, 10 and 15 years

Eligibility
Key inclusion criteria
- Male or female subjects, who are 40 to 75 years of age inclusive.

- Subjects who are able to give voluntary, written informed consent to participate in
this investigation and from whom written consent has been obtained.

- Subjects who, in the opinion of the Investigator, are able to understand this
investigation, co-operate with the investigational procedures and are willing to
return to the hospital for all the required post-operative follow-ups.

- Subjects who exhibit loss of articular cartilage which is predominantly confined to a
single compartment. The remaining compartments must be intact and able to bear normal
loads.

- Subjects who in the opinion of the Clinical Investigator are considered to be suitable
for treatment with the investigation device, according to the indications specified in
the package insert leaflet.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who, in the opinion of the Investigator, have an existing condition that
would compromise their participation and follow-up in this study.

- Subjects with a known history of poor compliance to medical treatment.

- Women who are pregnant.

- Subjects who are known drug or alcohol abusers or with psychological disorders that
could effect follow-up care or treatment outcomes.

- Subjects who have participated in a clinical study with an investigational product in
the last month.

- Subjects who are currently involved in any injury litigation claims.

- Revision of an existing unicompartmental implant.

- Subjects who have gross ligament laxity / instability.

- Subjects who have an inflammatory joint disease

- Subjects in whom there is evidence of previous joint sepsis

- Subjects who have a pre-operative flexion contracture of 15° or greater

- Subjects who have a pre-operative flexion of less than 90°

- Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus

- Subjects who have morbid obesity i.e. BMI > 40%

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
247
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Sportsmed SA, 32 Payneham, Stepney - Adelaide
Recruitment postcode(s) [1] 0 0
5069 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this investigation is to evaluate the surgical performance of the
DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a
Multi-centre setting.

The secondary objective of this investigation is to evaluate the long-term survivorship of
the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00734084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Dwyer, Ph.D
Address 0 0
DePuy Synthes Joint Reconstruction
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/ct2/show/NCT00734084