Osteoarthritis, KneeNCT05377450
Prospective Randomized Study of Cementless vs Cemented UKA
A study testing Engage Partial Knee in people with Osteoarthritis, Knee, run by JIS Research Institute at 1 site in United States.
Trial summary
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Engage Partial Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a pre-operative Knee Society Assessment Score of <70
- Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- Patients diagnosed with osteoarthritis (Kellgren Lawrence Grade IV) or avascular necrosis limited to the medial compartment of the operative knee joint
- Male or female patients who are at least 21 years of age at the time of surgery
- Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
- Patients with functionally intact ACL and PCL
Show all 13Show fewer
- Patients who need to obtain relief of pain and/or improved function in their knee
- Patients with fixed flexion deformity < 15°
- Patients who are able to follow post operative care instructions
- Patients who are willing and able to return for scheduled follow-up evaluations
- Patients in which natural alignment can be restored
- Patients with BMI < 40
- Patients who have completed a valid, IRB approved Informed Consent Form
Who cannot join
- Patients with a pre-operative Knee Society Assessment Score of ≥ 70
- Patients in which the device would be used to revise a failed prosthesis
- Patients who are less than 21 years of age at the time of surgery
- Disease or damage to the lateral part of the knee that in the investigator's opinion contraindicates a partial knee replacement
- Patients diagnosed with rheumatoid arthritis or other forms of inflammatory joint disease
- Patients diagnosed with a failed upper tibial osteotomy in the operative knee
Show all 43Show fewer
- Patients diagnosed with post-traumatic arthritis after tibial plateau fracture
- Patients who have had a patellectomy
- Patients with a flexion deformity > 15°
- Patients with a fixed varus deformity > 15°
- Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Patients with a fused knee on operative side
- Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk.
- Patient with pre-existing condition(s) that may interfere with the survival of the implant or their outcomes, including: Sickle Cell Anemia, Lower extremity muscular atrophy, Neuromuscular disease, Vascular insufficiency, Metabolic Disorders which impair bone formation, Paget's Disease, Charcot's Disease, Osteomalacia, Osteoporosis, Osteopenia.
- Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including: Immuno-compromised conditions (i.e. HIV), Hepatitis, Tuberculosis, Neoplastic disease such as cancer of the prostate, lung, stomach, cervix, etc.
- Chronic renal failure
- Organ transplant (i.e., heart, liver, lung, etc.) recipients
- Known disease process that in the opinion of the investigator may limit long term (4 year) follow up (i.e., multiple sclerosis, leukemia, lymphoma, etc.)
- Patients diagnosed with Parkinson's or Alzheimer's Disease
- Patients who have had an above-knee amputation in the contralateral leg Instability or deformity of the ligaments and/or surrounding soft tissue, which would preclude stability of the prostheses
- Patients with a known metal allergy
- Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent
- Patients who have received systemic steroids within the past 6 months or steroid injection into the affected knee within the previous 6 weeks prior to enrollment
- Patients taking immunosuppressives
- Patients who are pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
- Patients with severe valgus or varus knees (valgus or varus angulation of more than 20°) where collateral ligament, iliotibial band, or popliteal release is required
- Patients who refuse to sign the IRB approved Informed Consent Form
- Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months
- Patients with a history of osteomyelitis or sepsis of the index knee
- Patients who require patellar resurfacing
- Patients who are not skeletally mature
- Patients who have had a total hip replacement procedure <18 months prior to entering the study
- Patients who have had a contralateral non-study knee replacement procedure <18 months prior to entering the study
- Patients who are found intraoperatively to have inadequate bone stock or other conditions that contraindicate a partial knee replacement
- Patients who have a higher risk of falling
- Patients who are smokers or a history of smoking in the past 12 months
- Patients with alcoholism or drug addiction
- Tumors of the supporting bone structures
- Patients who have a permanent valgus or varus deformity including tibia vara deformity
- Patients with BMI ≥ 40
- Patients 80 years of age or older
- Patients who have undergone same-day or staged bi-lateral partial knee replacement
- Patients who may have an allergic reaction to the device materials or bone cement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study of Cementless Versus Cemented Unicompartmental Knee Arthroplasty (UKA)
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Read the detailed description
Medial unicompartmental knee arthroplasty has demonstrated outstanding success in the treatment of anteromedial osteoarthritis of the knee. Most UKA implants in the US market require cemented fixation, and there can be specific complications related to cement such as aseptic loosening between the bone-cement and/or cement-implant interface along with loose cement causing third-body wear of the remaining normal articular cartilage. Cementless devices offer a durable long-term fixation method with no risk of loose cement causing secondary damage.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Engage Partial Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engage Partial KneeDevice
Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement.
Engage Partial KneeDevice
Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system without bone cement.
| Study group | Role | What they receive |
|---|---|---|
| Cemented Engage Partial Knee | Active comparator | Engage partial knee implanted with bone cement for fixation. Receives: Device: Engage Partial Knee |
| Cementless Engage Partial Knee | Active comparator | Engage partial knee implanted with cementless fixation. Receives: Device: Engage Partial Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS JR Score
KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living.
Measured: 2 Years
Secondary outcomes (4)
Pain Score
Patient rated operative knee pain on a Likert pain score of 0-10.
Measured: 6 weeks; 3, 6, 9, 12 and 24 months
Range of Motion
Patient's range of motion is a measurement of the operated knee's extension and flexion.
Measured: 6 weeks; 3, 6, 9, 12 and 24 months
KOOS JR Score
KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living.
Measured: 6 weeks; 3, 6, 9, and 12 months
Implant Survivorship
Implant survivorship will be determined using revision surgery on the operated knee as implant failure.
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start29 Aug 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JIS Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- David A Crawford, MD, Principal investigator, JIS Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377450
- Sponsor's protocol ID
- 2022-Engage PKA
- Status last verified
- Mar 2025
- First submitted
- 12 May 2022
- Last updated
- 26 Mar 2025
- Results posted
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Cementless Versus Cemented Unicompartmental Knee Arthroplasty (UKA)
- ClinicalTrials.gov ID
- NCT05377450
- Acronym / sponsor ID
- 2022-Engage PKA
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- JIS Research InstituteUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 May 2022 (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.
To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Detailed description
Medial unicompartmental knee arthroplasty has demonstrated outstanding success in the treatment of anteromedial osteoarthritis of the knee. Most UKA implants in the US market require cemented fixation, and there can be specific complications related to cement such as aseptic loosening between the bone-cement and/or cement-implant interface along with loose cement causing third-body wear of the remaining normal articular cartilage. Cementless devices offer a durable long-term fixation method with no risk of loose cement causing secondary damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented Engage Partial Knee | Active comparator | Device: Engage Partial KneeEngage partial knee implanted with bone cement for fixation. |
| Cementless Engage Partial Knee | Active comparator | Device: Engage Partial KneeEngage partial knee implanted with cementless fixation. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with a pre-operative Knee Society Assessment Score of <70
- Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- Patients diagnosed with osteoarthritis (Kellgren Lawrence Grade IV) or avascular necrosis limited to the medial compartment of the operative knee joint
- Male or female patients who are at least 21 years of age at the time of surgery
- Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
Key exclusion criteria (43 listed)
- Patients with a pre-operative Knee Society Assessment Score of ≥ 70
- Patients in which the device would be used to revise a failed prosthesis
- Patients who are less than 21 years of age at the time of surgery
- Disease or damage to the lateral part of the knee that in the investigator's opinion contraindicates a partial knee replacement
- Patients diagnosed with rheumatoid arthritis or other forms of inflammatory joint disease
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 |
|---|---|---|
| Engage Partial KneeUnicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement. | Device | Cemented Engage Partial Knee |
| Engage Partial KneeUnicompartmental knee arthroplasty utilizing the Engage Partial Knee system without bone cement. | Device | Cementless Engage Partial Knee |
Primary outcome
KOOS JR Score
Time frame: 2 Years
KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living.
4 secondary outcomes
Pain Score
Time frame: 6 weeks; 3, 6, 9, 12 and 24 months
Range of Motion
Time frame: 6 weeks; 3, 6, 9, 12 and 24 months
KOOS JR Score
Time frame: 6 weeks; 3, 6, 9, and 12 months
Implant Survivorship
Time frame: 2 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
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.
David A Crawford, MD principal investigator
JIS Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engage Partial Knee in people with Osteoarthritis, Knee, run by JIS Research Institute 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 13 inclusion and 43 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
KOOS JR Score (time frame: 2 Years). 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 26 Mar 2025.