Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results

NCT02071745 | Completed

• 1 other identifier: ZIV-0041-13
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement is one of the most commonly performed orthopedic procedures. As of 2010, about 600,000 total knee replacements were being performed annually in the United States and these numbers are rising. The normal knee joint functions as a complex hinge allowing primarily flexion and extension, rotation and gliding. The knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). Damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inflammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties. A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems. The common techniques for Total knee replacement are:

1. 1.Conventional method TKR
2. 2.CT/MRI-based preoperative navigated TKR
3. 3.Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.

Conditions

Osteoarthrosis

Outcome Measures

Primary Outcomes (1)

• limb axis measurement

  surview CT images pre-( 1 week before the operation) and post-operatively(the day of operation) will be analyzed using the Traumacad software for limb axis. The navigation system results pre- and post-operatively will be given by the computer as an output at the Operation Theater. The results will be recorded for Varus/Valgus and degrees of deformity.

  An average, 1 week preoperatively up to 3 days postoperatively.

Secondary Outcomes (1)

• Clinical outcome and function

  up to 6 months postoperatively

Study Arms (1)

Navigation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing navigated total knee replacement

You may qualify if:

• age over 18
• severe osteoarthrosis of the knee
• failure of conservative treatment.

You may not qualify if:

• patients with severe vascular disease
• secondary knee deformation due to muscular atrophy or disease
• active infection
• morbid obesity
• neuropathic knee and osteomyelitis.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

ZIV medical center

Safed, Israel

Location

Related Publications (6)

• Mason JB, Fehring T, Fahrbach K. Navigated total knee replacement. J Bone Joint Surg Am. 2007 Nov;89(11):2547-8; author reply 2548; discussion 2548-50. doi: 10.2106/00004623-200711000-00032. No abstract available.

  PMID: 17974899 RESULT

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 RESULT

• Oswald MH, Jakob RP, Schneider E, Hoogewoud HM. Radiological analysis of normal axial alignment of femur and tibia in view of total knee arthroplasty. J Arthroplasty. 1993 Aug;8(4):419-26. doi: 10.1016/s0883-5403(06)80042-2.

  PMID: 8409995 RESULT

• Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):31-43.

  PMID: 8119035 RESULT

• Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.

  PMID: 6825330 RESULT

• Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS. Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res. 1993 Jan;(286):40-7.

  PMID: 8425366 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David E Rothem, MD

  Head of joint repalcement unit, Orthopedic department, Ziv medical center, Safed, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 26, 2014
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

IL (1)