Clinical trial NCT00733330: Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study
Official 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Primary endpoint: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA, specifically 3 months to demonstrate the variability of the mechanical axis.

Secondary endpoints: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA specifically to demonstrate the proportion of procedures that fall within a satisfactory alignment window in either group.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 - 12 Weeks
Secondary outcomes:
measure: 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.
timeFrame: operative
measure: 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.
timeFrame: 4 - 12 Weeks
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: Pre-op
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 4 Weeks
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 8 Weeks
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 12 Weeks
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 Months
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 1 year
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 2 years
measure: To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 5 years
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: pre-op
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 4 Weeks
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 8 Weeks
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 12 Weeks
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 Months
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 1 Year
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 2 years
measure: To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 5 years
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: pre-op
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 4 Weeks
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 8 weeks
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 12 weeks
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 months
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 1 year
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 2 years
measure: To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 5 years
measure: To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: pre-op
measure: To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 4 Weeks
measure: To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 8 Weeks
measure: To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 12 Weeks
measure: To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 months
measure: To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 5 years
measure: To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.
timeFrame: 5 years
measure: To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: pre-op
measure: To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 4 weeks
measure: To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 8 weeks
measure: To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 12 weeks
measure: To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
timeFrame: 6 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Orthopaedic Institute
state: California
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Pittsburgh
country: United States
facility: Joint Reconstruction Center, UPMC
state: Pennsylvania
city: Adelaide
country: Australia
facility: Sportsmed
state: South Australia
city: Remuera
country: New Zealand
facility: Ascot & Mercy Hospital
state: Aukland 5
Study officials:
References: