An observational study in Non-inflammatory Degenerative Joint Disease, sponsored by Smith & Nephew, Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Smith & Nephew, Inc. · Observational
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 131 is above the median of 100 across 601 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 2, 2026. See what changed
Investigators will pre-screen all subjects that have previously undergone UKA using the Journey UNI UKS system between 12 and 48 months previously using only the existing information in the medical records.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects previously received knee replacement
Device: Journey UNI Unicompartmental Knee System
Lateral or medial knee compartment replacement
Implant Survival
Revision-free implant survival at 5 years was determined by the proportion of participant knees with device survival. Revision-free implant survival was measured by a Kaplan-Meier survival estimate with survival defined as the absence of implant failure by the 5-year time point.
Time frame: 5 years
2011 Knee Society Score (KSS): Objective Knee Score
The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 111, with a higher score indicating a better outcome.
Time frame: Baseline, 1 year, 3 years, 5 years
2011 Knee Society Score (KSS): Expectation Score
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score was three items with a range of 3 to 15 where higher scores indicated a better outcome. The Expectation score indicated 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.
Time frame: Baseline, 1 year, 3 years, 5 years
2011 Knee Society Score (KSS): Satisfaction Knee Score
The 2011 Knee Society Score 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.
Time frame: Baseline, 1 year, 3 years, 5 years
2011 Knee Society Score (KSS): Functional Score
The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
Time frame: Baseline, 1 year, 3 years, 5 years
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The Quality of Life index (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a US country code scale of -0.573 to 1, with higher index values indicating better health and lower index values indicating worse health.
Time frame: 1 year, 3 years, 5 years
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visual Analogue Scale (VAS) Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.
Time frame: 1 year, 3 years, 5 years
Self-Administered Patient Satisfaction Survey (SAPSS): Surgery
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
Time frame: 1 year, 3 years, 5 years
Self-Administered Patient Satisfaction Survey (SAPSS): Pain
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery for improving your pain?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
Time frame: 1 year, 3 years, 5 years
Self-Administered Patient Satisfaction Survey (SAPSS): Work
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do home or yard work?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
Time frame: 1 year, 3 years, 5 years
Self-Administered Patient Satisfaction Survey (SAPSS): Recreational Activities
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do recreational activities?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
Time frame: 1 year, 3 years, 5 years
Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Mechanical Alignment
Perform weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine the mechanical alignment in degrees.
Time frame: Baseline, 6 months
Radiographic Findings: Implant Loosening
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine loosening of the implant (Yes/No).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Implant Subsidence/Migration
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine subsidence/migration of the implant (Yes/No).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Stress Shielding
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine presence of stress shielding (Yes/No).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Periprosthetic Fracture
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine periprosthetic fracture (Yes/No).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Wear of Articulating Surfaces of Replacement Components
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine wear of the articulating surfaces of replacement components (Yes/No).
Time frame: 1 year, 3 years, 5 years
Radiographic Findings: Radiolucencies
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines.
Time frame: 6 months, 1 year, 3 years, 5 years
Radiographic Findings: Femoral Zone Radiolucencies
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of femoral zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the femoral zone of the knee.
Time frame: 6 months, 1 year, 3 years, 5 years
Radiographic Findings: Anterior Medial-Lateral (ML) Zone Radiolucencies
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of anterior medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the anterior medial-lateral zone of the knee.
Time frame: 6 months, 1 year, 3 years, 5 years
Radiographic Findings: Lateral Medial-Lateral (ML) Zone Radiolucencies
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of lateral medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the lateral medial-lateral zone of the knee.
Time frame: 6 months, 1 year, 3 years, 5 years
Participants that previously underwent unicompartmental knee arthroplasty (UKA) using the study device were recruited across 4 investigative sites in the United States and Canada.
| Milestone | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Started | 129 |
| Completed | 109 |
| Not completed | 20 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Participant not able to return | 2 |
| Withdrew: Withdrawal by subject | 9 |
Revision-free implant survival at 5 years was determined by the proportion of participant knees with device survival. Revision-free implant survival was measured by a Kaplan-Meier survival estimate with survival defined as the absence of implant failure by the 5-year time point.
| proportion of knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Implant Survival | 0.986 (0.945 to 0.996) |
The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 111, with a higher score indicating a better outcome.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Baseline | 39.80 ± 15.30 |
| 1 year | 84.64 ± 10.56 |
| 3 years | 87.93 ± 15.44 |
| 5 years | 89.73 ± 14.63 |
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score was three items with a range of 3 to 15 where higher scores indicated a better outcome. The Expectation score indicated 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.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Baseline | 13.89 ± 1.47 |
| 1 year | 10.21 ± 3.09 |
| 3 years | 9.98 ± 3.00 |
| 5 years | 10.24 ± 3.12 |
The 2011 Knee Society Score 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.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Baseline | 13.39 ± 6.39 |
| 1 year | 31.83 ± 7.37 |
| 3 years | 33.70 ± 8.07 |
| 5 years | 34.13 ± 7.88 |
The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Baseline | 43.57 ± 12.35 |
| 1 year | 75.73 ± 16.24 |
| 3 years | 83.14 ± 15.29 |
| 5 years | 80.81 ± 18.55 |
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The Quality of Life index (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a US country code scale of -0.573 to 1, with higher index values indicating better health and lower index values indicating worse health.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year | 0.84 ± 0.10 |
| 3 years | 0.88 ± 0.11 |
| 5 years | 0.88 ± 0.12 |
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year | 84.33 ± 10.55 |
| 3 years | 83.76 ± 14.53 |
| 5 years | 83.02 ± 13.12 |
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Very satisfied | 26 |
| 1 year — Somewhat satisfied | 7 |
| 1 year — Somewhat dissatisfied | 0 |
| 1 year — Very dissatisfied | 0 |
| 3 years — Very satisfied | 108 |
| 3 years — Somewhat satisfied | 16 |
| 3 years — Somewhat dissatisfied | 8 |
| 3 years — Very dissatisfied | 0 |
| 5 years — Very satisfied | 103 |
| 5 years — Somewhat satisfied | 8 |
| 5 years — Somewhat dissatisfied | 8 |
| 5 years — Very dissatisfied | 1 |
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of your surgery for improving your pain?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Very satisfied | 25 |
| 1 year — Somewhat satisfied | 8 |
| 1 year — Somewhat dissatisfied | 0 |
| 1 year — Very dissatisfied | 0 |
| 3 years — Very satisfied | 104 |
| 3 years — Somewhat satisfied | 22 |
| 3 years — Somewhat dissatisfied | 6 |
| 3 years — Very dissatisfied | 1 |
| 5 years — Very satisfied | 103 |
| 5 years — Somewhat satisfied | 12 |
| 5 years — Somewhat dissatisfied | 3 |
| 5 years — Very dissatisfied | 2 |
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do home or yard work?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Very satisfied | 20 |
| 1 year — Somewhat satisfied | 13 |
| 1 year — Somewhat dissatisfied | 0 |
| 1 year — Very dissatisfied | 0 |
| 3 years — Very satisfied | 94 |
| 3 years — Somewhat satisfied | 30 |
| 3 years — Somewhat dissatisfied | 9 |
| 3 years — Very dissatisfied | 0 |
| 5 years — Very satisfied | 92 |
| 5 years — Somewhat satisfied | 20 |
| 5 years — Somewhat dissatisfied | 8 |
| 5 years — Very dissatisfied | 0 |
Self-Administered Patient Satisfaction Survey indicated the participants satisfaction with outcomes of joint replacement surgery across four domains of pain relief, home/yard work, recreational activities, and overall satisfaction by a response to a single question for each domain. Participants were categorized based on the question "How satisfied are you with the results of surgery for improving your ability to do recreational activities?" for the associated knee using one of the following responses: 1. Very satisfied 2. Somewhat satisfied 3. Somewhat dissatisfied 4. Very dissatisfied
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Very satisfied | 17 |
| 1 year — Somewhat satisfied | 14 |
| 1 year — Somewhat dissatisfied | 2 |
| 1 year — Very dissatisfied | 0 |
| 3 years — Very satisfied | 93 |
| 3 years — Somewhat satisfied | 25 |
| 3 years — Somewhat dissatisfied | 14 |
| 3 years — Very dissatisfied | 1 |
| 5 years — Very satisfied | 81 |
| 5 years — Somewhat satisfied | 28 |
| 5 years — Somewhat dissatisfied | 8 |
| 5 years — Very dissatisfied | 3 |
The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
| score on a scale | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year | 50.00 ± 27.51 |
| 3 years | 62.97 ± 27.76 |
| 5 years | 66.63 ± 31.85 |
Perform weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine the mechanical alignment in degrees.
| degrees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Baseline | 7.86 ± 2.76 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine loosening of the implant (Yes/No).
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Yes | 0 |
| 1 year — No | 86 |
| 3 years — Yes | 0 |
| 3 years — No | 135 |
| 5 years — Yes | 0 |
| 5 years — No | 120 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine subsidence/migration of the implant (Yes/No).
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Yes | 0 |
| 1 year — No | 86 |
| 3 years — Yes | 1 |
| 3 years — No | 134 |
| 5 years — Yes | 1 |
| 5 years — No | 119 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine presence of stress shielding (Yes/No).
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Yes | 0 |
| 1 year — No | 86 |
| 3 years — Yes | 0 |
| 3 years — No | 135 |
| 5 years — Yes | 0 |
| 5 years — No | 120 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine periprosthetic fracture (Yes/No).
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Yes | 0 |
| 1 year — No | 86 |
| 3 years — Yes | 0 |
| 3 years — No | 135 |
| 5 years — Yes | 0 |
| 5 years — No | 120 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine wear of the articulating surfaces of replacement components (Yes/No).
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 1 year — Yes | 0 |
| 1 year — No | 86 |
| 3 years — Yes | 0 |
| 3 years — No | 135 |
| 5 years — Yes | 0 |
| 5 years — No | 120 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines.
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 6 months — Radiolucencies All Negative: No | 17 |
| 6 months — Radiolucencies All Negative: Yes | 124 |
| 1 year — Radiolucencies All Negative: No | 27 |
| 1 year — Radiolucencies All Negative: Yes | 60 |
| 3 years — Radiolucencies All Negative: No | 48 |
| 3 years — Radiolucencies All Negative: Yes | 87 |
| 5 years — Radiolucencies All Negative: No | 33 |
| 5 years — Radiolucencies All Negative: Yes | 87 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of femoral zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the femoral zone of the knee.
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 6 months — Femoral Zone Radiolucencies All Negative: No | 9 |
| 6 months — Femoral Zone Radiolucencies All Negative: Yes | 132 |
| 1 year — Femoral Zone Radiolucencies All Negative: No | 14 |
| 1 year — Femoral Zone Radiolucencies All Negative: Yes | 73 |
| 3 years — Femoral Zone Radiolucencies All Negative: No | 33 |
| 3 years — Femoral Zone Radiolucencies All Negative: Yes | 102 |
| 5 years — Femoral Zone Radiolucencies All Negative: No | 19 |
| 5 years — Femoral Zone Radiolucencies All Negative: Yes | 101 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of anterior medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the anterior medial-lateral zone of the knee.
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 6 months — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 4 |
| 6 months — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 137 |
| 1 year — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 15 |
| 1 year — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 72 |
| 3 years — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 19 |
| 3 years — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 116 |
| 5 years — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 14 |
| 5 years — Anterior Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 106 |
Performed weight-bearing antero-posterior (A/P) and lateral standard x-rays to determine if presence of lateral medial-lateral (ML) zone radioloucencies were all negative (Yes/No). A 'Yes' response indicated no presence of radiolucent lines in the lateral medial-lateral zone of the knee.
| knees | Journey™ UNI Unicompartmental Knee System |
|---|---|
| 6 months — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 6 |
| 6 months — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 135 |
| 1 year — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 6 |
| 1 year — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 81 |
| 3 years — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 11 |
| 3 years — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 124 |
| 5 years — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: No | 18 |
| 5 years — Lateral Medial-Lateral (ML) Zone Radiolucencies All Negative: Yes | 102 |
Collected over Adverse events were collected during surgery to the last visit at 60 (±12) months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Journey™ UNI Unicompartmental Knee System | 1/129 (0.8%) | 35/129 (27.1%) | 52/129 (40.3%) |
| Event | Journey™ UNI Unicompartmental Knee System |
|---|---|
| SkeletalMusculoskeletal and connective tissue disorders | 11/129 |
| Injury, poisoning, or consequence of external causesInjury, poisoning and procedural complications | 4/129 |
| Muscular/Connective Tissue (generic musculoskeletal)Musculoskeletal and connective tissue disorders | 4/129 |
| Pain, unknown etiologyGeneral disorders | 4/129 |
| Cancer, known originNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/129 |
| InfectionInfections and infestations | 3/129 |
| RespiratoryRespiratory, thoracic and mediastinal disorders | 2/129 |
| Stiffness/limitation in movementInjury, poisoning and procedural complications | 2/129 |
| Cancer, unknown typeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/129 |
| CystNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/129 |
| Event | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Muscular/Connective Tissue (generic musculoskeletal)Musculoskeletal and connective tissue disorders | 21/129 |
| Pain at op site or in study kneeInjury, poisoning and procedural complications | 9/129 |
| EffusionInjury, poisoning and procedural complications | 8/129 |
| Injury, poisoning, or consequence of external causesInjury, poisoning and procedural complications | 6/129 |
| SkeletalMusculoskeletal and connective tissue disorders | 6/129 |
| Digestive/GastrointestinalGastrointestinal disorders | 5/129 |
| SwellingInjury, poisoning and procedural complications | 5/129 |
| Lateral knee painInjury, poisoning and procedural complications | 4/129 |
| Postoperative Flexion DeficitInjury, poisoning and procedural complications | 4/129 |
| Pain, unknown etiologyGeneral disorders | 3/129 |
Participants in the Intent to Treat (ITT) population included those that received study treatment with post-baseline data collected.
| Age, Continuous(years) | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Mean | 67.09 ± 8.62 |
| Sex: Female, Male(Participants) | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Female | 67 |
| Male | 62 |
| Ethnicity (NIH/OMB)(Participants) | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 122 |
| Unknown or Not Reported | 6 |
| Bilateral Status(Participants) | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Bilateral | 15 |
| Unilateral | 114 |
| Unknown | 0 |
| Body Mass Index(kg/m^2) | Journey™ UNI Unicompartmental Knee System |
|---|---|
| Mean | 29.04 ± 4.21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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