Clinical trial NCT02527148: A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
Official title: A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasties
Knee Replacement
Lead sponsor: Stryker South Pacific
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.


Eligibility criteria: Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 40-80 years.
* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
* Patient is deemed appropriate for a cruciate retaining knee replacement.
* 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, ethics-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 previous osteotomy around the knee.
* The patient is morbidly obese (BMI ≥ 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 a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
* The patient has a fixed flexion deformity ≥ 15°.
* 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).

Primary outcomes:
measure: Oxford Knee Score
timeFrame: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively
Secondary outcomes:
measure: Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)
timeFrame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
measure: Cost Effectiveness: Wound Length
timeFrame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
measure: Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure
timeFrame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
measure: Cost Effectiveness: Length of Stay in Hospital
timeFrame: 14 days
measure: Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L
timeFrame: 12 months
measure: Knee Pain
timeFrame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
measure: Health-related Quality of Life (EQ-5D-3L)
timeFrame: Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years
measure: The Forgotten Joint Score (FJS-12)
timeFrame: 6 week, 6 month, 12 month , 2 years and 5 years visits
measure: The International Knee Society Score (IKSS)
timeFrame: Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively
measure: Perth CT Protocol
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: