Total Knee ArthroplastyNCT06678750
A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
A study testing TKA using computer navigation and TKA in people with Total Knee Arthroplasty, run by Newton-Wellesley Hospital at 1 site in United States.
Trial summary
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- TKA using computer navigation and TKA
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant
Who cannot join
- Patients may be excluded due to some medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaplan Joint Center, Newton Wellesley Hospital
Newton, Massachusetts, 02468
About this study
Official title: Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA With Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: A Prospective Clinical Study
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
Read the detailed description
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
- Conditions
- Total Knee Arthroplasty
- Being tested
- TKA using computer navigation, TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKA using computer navigationDevice
TKA using Exactech GPS Newton Knee protocol
TKAProcedure or surgery
TKA using manual instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation | Active comparator | The comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation. Receives: Procedure: TKA |
| Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation | Experimental | The intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®). Receives: Device: TKA using computer navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.
Measured: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire
The OKS is a patient reported questionnaire that measures function and pain with a single score.
Measured: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire
The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.
Measured: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Patient recovery from TKA using time from hospital stay to discharge
The time of in-patient hospital stay will be measured (in hours).
Measured: Post-op measure in hours
Patient recovery from TKA by measuring number of outpatient visits
Number of outpatient visits (scheduled and unscheduled)
Measured: One year post-op
Patient recovery from TKA by measuring number of PT visits
Number of post-op PT visits
Measured: One year post-op
Patient recovery from TKA by measuring medication consumption
Post-op, prescription medication will be recorded in number of pills and dosage
Measured: One year post-op
Patient recovery from TKA by measuring use of assisted walking devices
Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.
Measured: One year post-op
Secondary outcomes (2)
Knee alignment and soft tissue balance
Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively.
Measured: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Knee alignment and soft tissue balance
Patients receiving a TKA NewtonTM Knee, soft-tissue balance will be measured intra-operatively by placing the Newton distractor at the trial reduction stage and acquiring the corresponding joint laxities through the arc of motion.
Measured: One time (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Study funding not finalized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newton-Wellesley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Exactech
- Responsible party
- Principal investigator, Christopher M. Melnic, MD, Newton-Wellesley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678750
- Sponsor's protocol ID
- 2024p002323
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA With Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06678750
- Acronym / sponsor ID
- 2024p002323
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study funding not finalized
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Newton-Wellesley HospitalUniversity, hospital or other
- Collaborators
- Exactech
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
Detailed description
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation | Active comparator | Procedure: TKAThe comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation. |
| Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation | Experimental | Device: TKA using computer navigationThe intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant
Key exclusion criteria (1 listed)
- Patients may be excluded due to some medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKA using computer navigationTKA using Exactech GPS Newton Knee protocol | Device | Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation |
| TKATKA using manual instrumentation | Procedure or surgery | Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation |
Primary outcome
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The KOOS, JR combines the pain, symptoms, and functional limitations into a single score.
Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The OKS is a patient reported questionnaire that measures function and pain with a single score.
Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions.
Patient recovery from TKA using time from hospital stay to discharge
Time frame: Post-op measure in hours
The time of in-patient hospital stay will be measured (in hours).
Patient recovery from TKA by measuring number of outpatient visits
Time frame: One year post-op
Number of outpatient visits (scheduled and unscheduled)
Patient recovery from TKA by measuring number of PT visits
Time frame: One year post-op
Number of post-op PT visits
Patient recovery from TKA by measuring medication consumption
Time frame: One year post-op
Post-op, prescription medication will be recorded in number of pills and dosage
Patient recovery from TKA by measuring use of assisted walking devices
Time frame: One year post-op
Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery.
2 secondary outcomes
Knee alignment and soft tissue balance
Time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op
Knee alignment and soft tissue balance
Time frame: One time (during surgery)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TKA using computer navigation and TKA in people with Total Knee Arthroplasty, run by Newton-Wellesley Hospital at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient satisfaction with TKA using patient reported KOOS JR Questionnaire (time frame: Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.