AzTrials
AzTrials

Arthroplasties, Replacement, KneeNCT02527161

Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B

A study testing ShapeMatch Cutting Guides with Triathlon in people with Arthroplasties, Replacement, Knee, run by Stryker South Pacific.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Arthroplasties, Replacement, Knee
What is being tested?
ShapeMatch Cutting Guides with Triathlon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
No sites listed yet
Study dates
Jun 2011to Apr 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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°.
Show all 13Show fewer
  • 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).

About this study

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

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.

Read the detailed description

Protocol Attached in documentation.

Being tested
ShapeMatch Cutting Guides with Triathlon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShapeMatch Cutting Guides with TriathlonDevice

    All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.

Study groups in NCT02527161
Study groupRoleWhat they receive
ShapeMatch Cutting Guides with TriathlonOtherThe ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only.
Receives: Device: ShapeMatch Cutting Guides with Triathlon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Location/Assessment of Alignment

    Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.

    Measured: 3 months Post-Operatively

Secondary outcomes (13)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)

    Measured: Pre-operative to 5 years post-operative

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)

    Measured: Pre-operative to 5 years post-operative

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)

    Measured: Pre-operative to 5 years post-operative

  4. Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)

    Measured: Pre-operative to 5 years Post-Operative

  5. Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.)

    Measured: Pre-operative to 5 years post-operative

  6. Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)

    SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.

    Measured: Pre-operative to 5 years Post-Operative

  7. VAS Pain at Rest

    Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.

    Measured: Pre-Operative to 5 years Post-Operative

  8. VAS Pain Mobilised

    Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.

    Measured: Pre-Operative to 5 years post-operative

  9. Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)

    SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.

    Measured: Pre-operative to 5 years Post-Operative

  10. Knee Society Clinical Rating System (KSS) Pain Scores

    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

    Measured: Pre-operative to 5 years Post-Operative

  11. Knee Society Clinical Rating System (KSS) Functional Scores

    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

    Measured: Pre-operative to 5 years Post-Operative

  12. Knee Society Clinical Rating System (KSS) Range of Motion Scores

    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

    Measured: Pre-operative to 5 years Post-Operative

  13. Forgotten Joint Score (FJS)

    The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100.

    Measured: 1 to 5 years Post-Operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startJun 2011
  3. Primary completionNov 2012
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527161
Sponsor's protocol ID
TriShapeMatch-10_SubStudyB
Status last verified
Sep 2020
First submitted
3 Aug 2015
Last updated
18 Sep 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing ShapeMatch Cutting Guides with Triathlon in people with Arthroplasties, Replacement, Knee, run by Stryker South Pacific.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Location/Assessment of Alignment (time frame: 3 months Post-Operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in