Comparison study of two different techniques for knee replacement

Not Applicable

Completed

• Conditions: Osteoarthritis of the knee; Musculoskeletal - Osteoarthritis; Surgery - Surgical techniques

• Registration Number: ACTRN12611000147987
• Lead Sponsor: Stryker Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-08
• Study Completion: 2018-04-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

The patient is a male or non-pregnant female between the ages of 50-80.
-The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
-The patient has a primary diagnosis of osteoarthritis (OA).
-The patient has intact collateral ligaments.
-The patient is able to undergo MRI scanning of the affected limb.
-The patient has signed the study specific, HREC-approved, Informed Consent document.
-The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria

-The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
-Patient has had a high tibial osteotomy or femoral osteotomy.
-The patient is morbidly obese (BMI is greater than or equal to 40).
-The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
-The patient has varus or valgus malalignment greater than or equal to 15 degrees (relative to mechanical axis).
-The patient has a fixed flexion deformity greater than or equal to 15 degrees.
-The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
-The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
-The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
-Patient has a cognitive impairment, an intellectual disability or a mental illness.
-The patient is pregnant.
-The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
-The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate, through calculation of Oxford Knee Score at 12 months postoperative, that total knee replacement (TKR) performed using the ShapeMatch Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation.[Pre-operatively and 6 weeks, 6 months and 12 months post-operatively.]