Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

Knee Arthritis Clinical Trial

Official title:

Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862316
• Other study ID #: CA4
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: June 15, 2017
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.

Description:

The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria for the Oxford Knee

• symptomatic unicompartmental knee arthritis major surgery

• failed non operative treatment modalities

• willing and able to give informed consent

• skeletal maturity

Exclusion criteria for the Oxford Knee

• medical conditions that preclude general or spinal anesthetic

• ipsilateral knee avascular necrosis

• severe osteoporosis or osteopenia

• neuromuscular impairment

• ipsilateral knee infection

Patient day surgery criteria

• medically stable: an ASA category of 1 or 2

• close proximity to the hospital surgery performed for at least 36 hours

• good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op.

• hemovac to be removed prior to discharge

• access to VON or other home care hospital approved services

• pain buster for pain control for 24 to 36 hours

Related Conditions & MeSH terms

• Arthritis
• Knee Arthritis

Intervention

Device:
• Oxford Unicompartmental Knee
Knee Arthroplasty

Locations

Country	Name	City	State
Canada	Dartmouth General Hospital	Dartmouth	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Dartmouth General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Kreibich DN, Vaz M, Bourne RB, Rorabeck CH, Kim P, Hardie R, Kramer J, Kirkley A. What is the best way of assessing outcome after total knee replacement? Clin Orthop Relat Res. 1996 Oct;(331):221-5. — View Citation

Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. — View Citation

Price AJ, Webb J, Topf H, Dodd CA, Goodfellow JW, Murray DW; Oxford Hip and Knee Group. Rapid recovery after oxford unicompartmental arthroplasty through a short incision. J Arthroplasty. 2001 Dec;16(8):970-6. — View Citation

Svärd UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. J Bone Joint Surg Br. 2001 Mar;83(2):191-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative record		Immediately Post-Op
Primary	Visual Analogue for pain, activity, and patient satisfaction (VAS)		1 year
Primary	American Knee Society Score (AKSS)		1 year
Secondary	Oxford Knee 12		1 year
Secondary	Western Ontario MacMaster(WOMAC)		1 year
Secondary	SF 12		1 year
Secondary	Gait Belt Analysis		1 year
Secondary	Radiographic Output		1 year