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

NCT00733330 | Terminated Phase 4 Results

• 1 other identifier: CT 03/10
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 5

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.

Conditions

Osteoarthritis

Keywords

Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  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.

  4 - 12 Weeks

• To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

  Pre-op

• To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

  4 Weeks

• To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.

  8 Weeks

Study Arms (2)

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

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

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

Interventions

Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique DEVICE

Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation

Conventional TKR arm

Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation DEVICE

Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

MiTKR CAS arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (5)

Newport Orthopaedic Institute

Newport Beach, California, 92651, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Joint Reconstruction Center, UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

Sportsmed

Adelaide, South Australia, 5069, Australia

Location

Ascot & Mercy Hospital

Remuera, Aukland 5, New Zealand

Location

MeSH Terms

Conditions

Osteoarthritis; Apraxias

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kimberly Dwyer
• Organization: DePuy International

kdwyer2@its.jnj.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

US (3); AU (1); NZ (1)