OsteoarthritisPhase 4NCT00733330

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

A Phase 4 study testing Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique and Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation in people with Osteoarthritis, run by DePuy International at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Osteoarthritis
What is being tested?: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique and Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 5 sitesin 3 countries
Study dates: Jan 2005to Dec 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

5 sites in 3 countries.

Country

City, postcode or hospital

5 sites in 3 countries

United States3 sites

Newport Orthopaedic Institute
Newport Beach, California, 92651
Joint Reconstruction Center, UPMC
Pittsburgh, Pennsylvania, 15232
Wake Forest University
Winston-Salem, North Carolina, 27106

Other trials in United States

Australia1 site

Sportsmed
Adelaide, South Australia, 5069

Other trials in Australia

New Zealand1 site

Ascot & Mercy Hospital
Remuera, Aukland 5

Other trials in New Zealand

About this 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.

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.

Read the 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.

Conditions: Osteoarthritis
Being tested: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique, Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation
Keywords: Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive
Medical subject headings: Osteoarthritis, Apraxias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical techniqueDevice
Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigationDevice
Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

Study groups in NCT00733330
Study group	Role	What they receive
Conventional TKR arm	Other	Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique Receives: Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
MiTKR CAS arm	Active comparator	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 Receives: Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (38)

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.
An independent radiographic observer will determine and record alignment.
Measured: operative
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.
Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.
Measured: 4 - 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: Pre-op
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
The 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.
Measured: 4 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 8 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 6 Months
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 1 year
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 2 years
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 5 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: pre-op
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 4 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 8 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 12 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 6 Months
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 1 Year
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 2 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 5 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: pre-op
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 4 Weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 8 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 12 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 6 months
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 1 year
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 2 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 5 years
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: pre-op
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 4 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 8 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 12 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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.
Measured: 6 months
To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
An independent radiographer will observe and record alignment.
Measured: 5 years
To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.
An independent radiographer will observe and record alignment
Measured: 5 years
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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). Pre-operatively, the subject must complete both a practice walk and a test walk.
Measured: pre-op
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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).
Measured: 4 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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).
Measured: 8 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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).
Measured: 12 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Dec 2010

First posted13 Aug 2008 (estimated)
Study startJan 2005
Primary completionDec 2008
Study completionDec 2010

Why it stopped: A sample size recalculation indicated an increase from 154 to 1500 subjects was required so the study stopped as new target was considered unfeasible.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00733330
Sponsor's protocol ID: CT 03/10
Status last verified: Jul 2014
First submitted: 11 Aug 2008
Last updated: 15 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00733330
Acronym / sponsor ID: CT 03/10
Conditions: Osteoarthritis
Keywords: Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: A sample size recalculation indicated an increase from 154 to 1500 subjects was required so the study stopped as new target was considered unfeasible.
Enrolment: 86 participants (actual)
Lead sponsor: DePuy InternationalIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Dec 2008 (actual)
Study completion: Dec 2010 (actual)
First posted: 13 Aug 2008 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 Adverse Events experienced by the subjects who have undergone the two types of procedure.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional TKR arm	Other	Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical techniquePatients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
MiTKR CAS arm	Active comparator	Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigationPatients 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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical techniqueOrthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation	Device	Conventional TKR arm
Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigationOrthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation	Device	MiTKR CAS arm

Primary outcome

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

38 secondary outcomes

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.
Time frame: operative
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.
Time frame: 4 - 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: Pre-op
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 4 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 8 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 12 Weeks
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 6 Months
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 1 year
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 2 years
To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 5 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: pre-op
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 4 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 8 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 12 Weeks
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 6 Months
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 1 Year
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 2 years
To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 5 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: pre-op
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 4 Weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 8 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 12 weeks
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 6 months
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 1 year
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 2 years
To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 5 years
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: pre-op
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 4 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 8 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 12 Weeks
To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 6 months
To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 5 years
To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.
Time frame: 5 years
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: pre-op
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 4 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 8 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 12 weeks
To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.
Time frame: 6 months

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MiTKR CAS Arm	32	30
Conventional TKR Arm	52	48

Primary outcome: To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

Time frame: 6 - 12 Weeks

Population analysed: The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.

38 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline through December 2008.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MiTKR CAS Arm	2 of 32 (6.3%)	4 of 32 (12.5%)	Not reported
Conventional TKR Arm	9 of 52 (17.3%)	7 of 52 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty. (time frame: 6 - 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.