ArthroplastyNCT04849884

To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.

A study testing CORI™ KNEE TENSIONER in people with Arthroplasty and Replacement, run by Smith & Nephew, Inc. at 4 sites in United States.

Completed

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

Official record

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Trial summary

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: CORI™ KNEE TENSIONER
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 4 sitesUnited States
Study dates: 30 Mar 2022to 4 Jun 2025
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
Subject is eighteen (18) years old or older.
Subject is willing and able to attend all study follow-up visits for up to one (1) year postoperatively (as defined in the study protocol and ICF).
Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
Subject is suitable for the CORI™ Surgical System.
Subject requires a cemented TKA as a primary indication due to any of the following conditions:

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Degenerative joint disease, including osteoarthritis
Rheumatoid arthritis.
Avascular necrosis.
Requires correction of functional deformity
Requires treatment of fractures that were unmanageable using other techniques.

Who cannot join

Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
Subjects who are non-English speaking.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155.
Subjects who have participated previously in this clinical trial

Show all 23Show fewer

Subjects with a history of poor compliance with medical treatment.
Subject needs a CORI™ Surgical System TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard TKA (e.g., stems, augments, or custom-made devices).
Subject has been diagnosed with post-traumatic arthritis
Subject needs a bilateral TKA.
Subject has active infection or sepsis (treated or untreated)
Subject is morbidly obese with a body mass index (BMI) greater than 40.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study. This includes:
Advanced osteoarthritis
Joint disease
Paget's or Charcot's disease
Vascular insufficiency
Muscular atrophy
Uncontrolled diabetes
Moderate to severe renal insufficiency
Neuromuscular disease
Mental illness or mental retardation
Drug or alcohol abuse

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Tamarack Health
Ashland, Wisconsin, 54806
Mount Carmel Research Institute
New Albany, Ohio, 43054
Hospital for Special Surgery
New York, New York, 10021
University of Pittsburgh, Magee
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Prospective, Multi-Center, Post-Market Clinical Study to Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System in Total Knee Arthroplasty Procedures.

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

Read the detailed description

This is a post-market, prospective, multicenter, open-label study evaluating the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System at approximately 4 centers across the United States. Ninety (90) patients eligible for a robotic-assisted TKA procedure with the CORI™ Surgical System will be followed for approximately 12 months.

The CORI™ KNEE TENSIONER is an accessory to REAL INTELLIGENCE™ CORI™ Surgical System. The TENSIONER may assist the surgeon in providing consistent varus and valgus stress during gap assessment before making any bony resections. The TENSIONER communicates directly with CORI software, providing automated data collection.

The primary objective is to evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System by assessing patient satisfaction with the EQ-5D-5L VAS.

Conditions: Arthroplasty, Replacement, Knee
Being tested: CORI™ KNEE TENSIONER
Keywords: Total Knee Arthroplasty (TKA), Robotic, CORI™ KNEE TENSIONER, CORI

What participants receive

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

CORI™ KNEE TENSIONERDevice
Robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.

Study groups in NCT04849884
Study group	Role	What they receive
CORI™ KNEE TENSIONER	Experimental	Participant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory. Receives: Device: CORI™ KNEE TENSIONER

What is being measured

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

EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L VAS score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The EQ-5D-5L VAS score records the participant's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 0 to 100 where 0 is the worst imaginable health state and 100 is the best imaginable health state (i.e., a higher score was a better outcome).
Measured: Baseline, 6 weeks, 6 months, 12 months

Secondary outcomes (5)

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L Index score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) to create a combined Health Index Score. The combined Health Index Score is on a scale of 0 to 1 with a higher score indicating a better outcome.
Measured: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Objective Score. The KSS consists of 4 separate sub-scales. The Objective Knee Score is seven items with a range of 0 to 100, with a higher score indicating a better outcome.
Measured: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Function Score. The KSS consists of 4 separate sub-scales. The Function Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. The Function Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
Measured: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Change from baseline to 6 weeks, 6 months, and 12 months in the 2011 Knee Society Score (KSS) Satisfaction Score. The KSS consists of 4 separate sub-scales. The Patient Satisfaction Score is five items with a range of 0 to 40, with a higher score indicating a better outcome.
Measured: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
The 2011 Knee Society Score (KSS) consists of 4 separate sub-scales. The Patient Expectation Score is three items with a range of 0 to 15, with a higher score indicating a better outcome. The Expectation score indicates the patient's opinion on the extent they expect the operation to improve their knee pain, and ability to perform activities of daily living and recreational activities.
Measured: Baseline, 6 weeks, 6 months, 12 months

Timeline

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

30 Mar 20224 Jun 2025

First posted19 Apr 2021
Study start30 Mar 2022
Primary completion4 Jun 2025
Study completion4 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArthroplastyStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849884
Sponsor's protocol ID: CORI TENSIONER.2020.04
Status last verified: Aug 2025
First submitted: 9 Apr 2021
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Post-Market Clinical Study to Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System in Total Knee Arthroplasty Procedures.
ClinicalTrials.gov ID: NCT04849884
Acronym / sponsor ID: CORI TENSIONER.2020.04
Conditions: Arthroplasty, Replacement, Knee
Keywords: Total Knee Arthroplasty (TKA), Robotic, CORI™ KNEE TENSIONER, CORI
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 30 Mar 2022 (actual)
Primary completion: 4 Jun 2025 (actual)
Study completion: 4 Jun 2025 (actual)
First posted: 19 Apr 2021 (actual)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

Detailed description

The primary objective is to evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System by assessing patient satisfaction with the EQ-5D-5L VAS.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CORI™ KNEE TENSIONER	Experimental	Device: CORI™ KNEE TENSIONERParticipant having a robotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subject agrees to consent to the study by signing the Independent Review Board (IRB) approved ICF.
Subject is eighteen (18) years old or older.
Subject is willing and able to attend all study follow-up visits for up to one (1) year postoperatively (as defined in the study protocol and ICF).
Subject can read, understand, and communicate responses to Patient Reported Outcome Measures (PROMs).
Subject is suitable for the CORI™ Surgical System.

Key exclusion criteria (23 listed)

Contraindications or hypersensitivity to the use of the CORI™ Surgical System per the IFU.
Participation in the treatment period of another clinical trial within thirty (30) days of the Pre-Operative Visit, or during the study.
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures.
Subjects who are non-English speaking.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155.

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
CORI™ KNEE TENSIONERRobotic TKA procedure with the REAL INTELLIGENCE™ CORI™ Surgical System including the use of the CORI™ KNEE TENSIONER accessory.	Device	CORI™ KNEE TENSIONER

Primary outcome

EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months
Change from baseline to 6 weeks, 6 months, and 12 months in EQ-5D-5L VAS score. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system (i.e., Index score) and the EQ Visual Analogue scale (i.e., VAS score). The EQ-5D-5L VAS score records the participant's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 0 to 100 where 0 is the worst imaginable health state and 100 is the best imaginable health state (i.e., a higher score was a better outcome).

5 secondary outcomes

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Objective Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Function Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Satisfaction Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months
2011 Knee Society Score (KSS): Expectation Score at Baseline, 6 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 6 weeks, 6 months, 12 months

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CORI™ KNEE TENSIONER	77	64

Primary outcome: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months

Time frame: Baseline, 6 weeks, 6 months, 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	CORI™ KNEE TENSIONER n = 69
Change from Baseline to 6 weeks	3 (15)
Change from Baseline to 6 months	7 (16)
Change from Baseline to 12 months	8 (17)

Population analysed: The Full Analysis Set (FAS) Population included all participants enrolled into the study that had at least one post-baseline effectiveness assessment with data collected for the indicated outcome measure at the time frame specified.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during surgery to study completion, approximately 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CORI™ KNEE TENSIONER	17 of 77 (22.1%)	25 of 77 (32.5%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CORI™ KNEE TENSIONER in people with Arthroplasty and Replacement, run by Smith & Nephew, Inc. at 4 sites 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 11 inclusion and 23 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 30 Jun 2026). 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?

EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score Change From Baseline to 6 Weeks, 6 Months, and 12 Months (time frame: Baseline, 6 weeks, 6 months, 12 months). 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 NCT04849884.

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 30 Jun 2026.