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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00733330




Registration number
NCT00733330
Ethics application status
Date submitted
11/08/2008
Date registered
13/08/2008
Date last updated
15/08/2014

Titles & IDs
Public title
Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study
Scientific title
Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.
Secondary ID [1] 0 0
CT 03/10
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 - Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
Treatment: Devices - Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

Other: Conventional TKR arm - Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Active comparator: MiTKR CAS arm - Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation


Treatment: Devices: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation

Treatment: Devices: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation
Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [1] 0 0
6 - 12 Weeks
Secondary outcome [1] 0 0
To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [1] 0 0
operative
Secondary outcome [2] 0 0
To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [2] 0 0
4 - 12 Weeks
Secondary outcome [3] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [3] 0 0
Pre-op
Secondary outcome [4] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [4] 0 0
4 Weeks
Secondary outcome [5] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [5] 0 0
8 Weeks
Secondary outcome [6] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [7] 0 0
6 Months
Secondary outcome [8] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [10] 0 0
5 years
Secondary outcome [11] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [11] 0 0
pre-op
Secondary outcome [12] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [12] 0 0
4 Weeks
Secondary outcome [13] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [13] 0 0
8 Weeks
Secondary outcome [14] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [14] 0 0
12 Weeks
Secondary outcome [15] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [15] 0 0
6 Months
Secondary outcome [16] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [16] 0 0
1 Year
Secondary outcome [17] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [17] 0 0
2 years
Secondary outcome [18] 0 0
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [18] 0 0
5 years
Secondary outcome [19] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [19] 0 0
pre-op
Secondary outcome [20] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [20] 0 0
4 Weeks
Secondary outcome [21] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [21] 0 0
8 weeks
Secondary outcome [22] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [22] 0 0
12 weeks
Secondary outcome [23] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [23] 0 0
6 months
Secondary outcome [24] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [24] 0 0
1 year
Secondary outcome [25] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [25] 0 0
2 years
Secondary outcome [26] 0 0
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [26] 0 0
5 years
Secondary outcome [27] 0 0
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [27] 0 0
pre-op
Secondary outcome [28] 0 0
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [28] 0 0
4 Weeks
Secondary outcome [29] 0 0
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [29] 0 0
8 Weeks
Secondary outcome [30] 0 0
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [30] 0 0
12 Weeks
Secondary outcome [31] 0 0
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [31] 0 0
6 months
Secondary outcome [32] 0 0
To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [32] 0 0
5 years
Secondary outcome [33] 0 0
To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.
Timepoint [33] 0 0
5 years
Secondary outcome [34] 0 0
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [34] 0 0
pre-op
Secondary outcome [35] 0 0
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [35] 0 0
4 weeks
Secondary outcome [36] 0 0
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [36] 0 0
8 weeks
Secondary outcome [37] 0 0
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [37] 0 0
12 weeks
Secondary outcome [38] 0 0
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Timepoint [38] 0 0
6 months

Eligibility
Key inclusion criteria
* Male or female subjects aged between 18 and 80 years inclusive.
* Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
* Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation.
* Subjects who have given consent to the transfer of his/her information to DePuy.
* Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
* Subjects who have a fixed flexion contracture of greater than 10º.
* Subjects who are clinically obese i.e. BMI =30.
* Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
* Female subjects who are pregnant or lactating.
* Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical investigation with an investigational product in the last 3 months.
* Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
* Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee.
* Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy.
* Subjects who require simultaneous bilateral total knee replacements.
* Subjects who have had a contralateral TKA performed less than six months before the proposed TKA.
* Subjects who have had a contralateral TKA and that knee was previously entered in the study.
* Subjects who, in the opinion of the surgeon, will require a contralateral TKA within 6 months of the index procedure.
* Subjects in whom the surgeon intends to implant a knee component that is not one of those listed in Table 1.
* Subjects who have inflammatory arthritis.

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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Sportsmed - Adelaide
Recruitment postcode(s) [1] 0 0
5069 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
New Zealand
State/province [4] 0 0
Aukland 5

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to:

Compare the accuracy of long leg alignment achieved by the two types of procedure.

Compare the number of optimal implantations achieved by the two types of procedure.

Compare the clinical performance of the knee replacement in subjects who have undergone one of the two types of procedure.

Compare the functional outcome achieved by subjects who have undergone one of the two types of procedure.

Compare the interface radiographic appearance 5 years post-operatively between the two types of procedure.

Compare the accuracy and precision of long leg alignment achieved by the two types of procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy and precision between the final follow-up and baseline.

Compare the Adverse Events experienced by the subjects who have undergone the two types of procedure.
Trial website
https://clinicaltrials.gov/study/NCT00733330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00733330