Clinical trial NCT02527161: Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Official title: A Prospective, Non-randomized, Longitudinal Study of the Clinical Outcomes of Participants That Receive the Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasties, Replacement, Knee
Lead sponsor: Stryker South Pacific
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 205
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.

Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.

Detailed description: Protocol Attached in documentation.

Eligibility criteria: Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 50-90.
* 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.
* The patient has had a high tibial osteotomy or femoral osteotomy.
* 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.
* The 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: Implant Location/Assessment of Alignment
timeFrame: 3 months Post-Operatively
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain
timeFrame: Pre-operative to 5 years post-operative
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms
timeFrame: Pre-operative to 5 years post-operative
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL
timeFrame: Pre-operative to 5 years post-operative
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R
timeFrame: Pre-operative to 5 years Post-Operative
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL
timeFrame: Pre-operative to 5 years post-operative
measure: Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)
timeFrame: Pre-operative to 5 years Post-Operative
measure: VAS Pain at Rest
timeFrame: Pre-Operative to 5 years Post-Operative
measure: VAS Pain Mobilised
timeFrame: Pre-Operative to 5 years post-operative
measure: Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)
timeFrame: Pre-operative to 5 years Post-Operative
measure: Knee Society Clinical Rating System (KSS) Pain Scores
timeFrame: Pre-operative to 5 years Post-Operative
measure: Knee Society Clinical Rating System (KSS) Functional Scores
timeFrame: Pre-operative to 5 years Post-Operative
measure: Knee Society Clinical Rating System (KSS) Range of Motion Scores
timeFrame: Pre-operative to 5 years Post-Operative
measure: Forgotten Joint Score (FJS)
timeFrame: 1 to 5 years Post-Operative
Other outcomes:
Locations:
Study officials:
References: