Osteoarthritis, KneeNCT03511144
A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
A study testing Unity Knee™ TKR using measured resection and Unity Knee™ TKR using ligament balancing in people with Osteoarthritis, Knee and Rheumatoid Arthritis, run by Corin.
Trial summary
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee
- What is being tested?
- Unity Knee™ TKR using measured resection and Unity Knee™ TKR using ligament balancing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2020
- 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
- Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
- Over 18 years old
- Male and female subjects who are skeletally mature
- Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
- Subjects able to understand what is expected of them and be able to comply with the study protocol requirements
Who cannot join
- Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
- Any subject with fixed flexion contracture greater than 20 degrees
- Any subject with varus/valgus deformity greater than 15 degrees
- Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
- Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
- Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
Show all 12Show fewer
- Any subject with a known sensitivity to device material
- Any subject who is pregnant
- Any subject currently a prisoner
- Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
- Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
- Any subject unable to read and understand English
About this study
Official title: A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee, Varus Deformity, Not Elsewhere Classified, Knee, Valgus Deformity, Not Elsewhere Classified, Knee, Flexion Deformity, Knee
- Being tested
- Unity Knee™ TKR using measured resection, Unity Knee™ TKR using ligament balancing
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unity Knee™ TKR using measured resectionDevice
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
Unity Knee™ TKR using ligament balancingDevice
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Measured resection | Active comparator | Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique Receives: Device: Unity Knee™ TKR using measured resection |
| Ligament balancing | Active comparator | Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique Receives: Device: Unity Knee™ TKR using ligament balancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior condylar offset (PCO)
Any difference in PCO from preoperative to 6 weeks post-surgery
Measured: 6 weeks post-op
Secondary outcomes (11)
Joint line in extension
Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery
Measured: 6 weeks post-op
Joint line in flexion
Any difference in medial joint line position measured using the PCO
Measured: 6 weeks post-op
Femoral flexion angle
Measured: 6 weeks post-op
Distal femoral component angle
Measured: 6 weeks post-op
Tibial component angle
Measured: 6 weeks post-op
Tibial slope
Measured: 6 weeks post-op
Hip-knee-ankle (HKA) angle
Measured: 6 weeks post-op
Oxford Knee Score (OKS)
Measured: Up to 24 months post-op
Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)
Measured: Up to 24 months post-op
EuroQoL 5-dimension health state (EQ-5D 5-level)
Measured: Up to 6 months post-op
Hospital Anxiety and Depression Scale (HADS)
Measured: Up to 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startJul 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Study not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511144
- Sponsor's protocol ID
- CSP2015-04
- Status last verified
- Nov 2018
- First submitted
- 11 Apr 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System
- ClinicalTrials.gov ID
- NCT03511144
- Acronym / sponsor ID
- CSP2015-04
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee, Varus Deformity, Not Elsewhere Classified, Knee, Valgus Deformity, Not Elsewhere Classified, Knee, Flexion Deformity, Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- Jul 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 27 Apr 2018 (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.
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measured resection | Active comparator | Device: Unity Knee™ TKR using measured resectionTotal knee replacement using the Unity Knee™ implanted with the measured resection surgical technique |
| Ligament balancing | Active comparator | Device: Unity Knee™ TKR using ligament balancingTotal knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
- Over 18 years old
- Male and female subjects who are skeletally mature
- Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
- Subjects able to understand what is expected of them and be able to comply with the study protocol requirements
Key exclusion criteria (12 listed)
- Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
- Any subject with fixed flexion contracture greater than 20 degrees
- Any subject with varus/valgus deformity greater than 15 degrees
- Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
- Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
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 |
|---|---|---|
| Unity Knee™ TKR using measured resectionTotal knee replacement using the Unity Knee™ implanted with the measured resection surgical technique | Device | Measured resection |
| Unity Knee™ TKR using ligament balancingTotal knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique | Device | Ligament balancing |
Primary outcome
Posterior condylar offset (PCO)
Time frame: 6 weeks post-op
Any difference in PCO from preoperative to 6 weeks post-surgery
11 secondary outcomes
Joint line in extension
Time frame: 6 weeks post-op
Joint line in flexion
Time frame: 6 weeks post-op
Femoral flexion angle
Time frame: 6 weeks post-op
Distal femoral component angle
Time frame: 6 weeks post-op
Tibial component angle
Time frame: 6 weeks post-op
Tibial slope
Time frame: 6 weeks post-op
Hip-knee-ankle (HKA) angle
Time frame: 6 weeks post-op
Oxford Knee Score (OKS)
Time frame: Up to 24 months post-op
Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)
Time frame: Up to 24 months post-op
EuroQoL 5-dimension health state (EQ-5D 5-level)
Time frame: Up to 6 months post-op
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 6 months post-op
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 21 Nov 2018.
Related trials for Osteoarthritis, Knee
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Unity Knee™ TKR using measured resection and Unity Knee™ TKR using ligament balancing in people with Osteoarthritis, Knee and Rheumatoid Arthritis, run by Corin.
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 5 inclusion and 12 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 21 Nov 2018. 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?
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?
Posterior condylar offset (PCO) (time frame: 6 weeks post-op). 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 21 Nov 2018.