Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study

Phase 4

Terminated

Conditions: Osteoarthritis

Interventions: Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

Registration Number: NCT00733330

Lead Sponsor: DePuy International

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 86

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional TKR arm	Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique	Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
MiTKR CAS arm	Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation	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

Primary Outcome Measures

Name	Time	Method
To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	6 - 12 Weeks	Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)

Secondary Outcome Measures

Name	Time	Method
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	6 months	This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).
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.	4 - 12 Weeks	Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	6 months	A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.
To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.	5 years	An independent radiographer will observe and record alignment
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.	operative	An independent radiographic observer will determine and record alignment.
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	5 years	American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	5 years	The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	5 years	WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.
To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.	5 years	An independent radiographer will observe and record alignment.

Trial Locations

Locations (5): Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
Ascot & Mercy Hospital
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Remuera, Aukland 5, New Zealand
Newport Orthopaedic Institute
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Newport Beach, California, United States
Joint Reconstruction Center, UPMC
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Pittsburgh, Pennsylvania, United States
Sportsmed
🇦🇺
Adelaide, South Australia, Australia