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

Osteoarthrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071745
• Other study ID #: ZIV-0041-13
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 22, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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. Conventional method TKR

2. CT/MRI-based preoperative navigated TKR

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.

We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.

Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age over 18

• severe osteoarthrosis of the knee

• failure of conservative treatment.

Exclusion Criteria:

• patients with severe vascular disease

• secondary knee deformation due to muscular atrophy or disease

• active infection

• morbid obesity

• neuropathic knee and osteomyelitis.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthrosis

Locations

Country	Name	City	State
Israel	ZIV medical center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Clinical outcome and function	the clinical evaluation of the patient will be based on the knee society scoring system: Range of movement(degrees), pain level(1-lowest,10-highest), anterior-posterior stability(mm), mediolateral stability(degrees), function test based on walking,climbing stairs, use of walking aids. The results will be summed up and give a numerical score.	up to 6 months postoperatively	No