A study of patient-specific cutting guides for total knee joint replacement.

Not Applicable

Completed

• Conditions: Musculoskeletal - Osteoarthritis; Osteoarthritis of the knee

• Registration Number: ACTRN12610000192088
• Lead Sponsor: Stryker Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-03
• Study Completion: 2018-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

1. The patient is a male or non-pregnant female between the ages of 50-90.
2. The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
3. The patient has a primary diagnosis of osteoarthritis (OA).
4. The patient has intact collateral ligaments.
5. The patient is able to undergo MRI scanning of the affected limb.
6. The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Informed Consent document.
7. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria

1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
2. Patient has had a high tibial osteotomy or femoral osteotomy.
3. The patient is morbidly obese (Body Mass Index, BMI = 40).
4. The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
5. The patient has a varus/valgus malalignment = 15 degrees.
6. The patient has a fixed flexion deformity = 15 degrees.
7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
10. Patient has a cognitive impairment, an intellectual disability or a mental illness.
11. The patient is pregnant.
12. The patient has no metal hardware present in the region of the hip, knee or ankle
13. The patient has any known contraindications for undergoing assessment by MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precision of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement.[Intra-operatively.];Radiographic implant location, consisting of multiparameter assessment of the relative position and orientation of the femoral and tibial components and overall limb alignment, assessed by the Perth CT protocol.[3 months post-op.]

Secondary Outcome Measures

Name	Time	Method
Knee function before and after surgery using International Knee Society Score (IKS) and Knee injury and Osteoarthritis Outcome Score (KOOS).[Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.];Quality of life before and after surgery assessed by Short Form (SF)-12.[Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.];Pain assessed by Visual Analogue Scale (VAS).[Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.]