Patient Reported Outcome MeasureNCT04419129
Comparison of Functional Recovery Between Mobile Bearing Unicompartmental Knee Arthroplasty and Total Knee Arthroplasty
A study testing Oxford UKA and Vanguard TKA in people with Patient Reported Outcome Measure, run by Thammasat University at 1 site in Thailand.
Trial summary
The total knee replacement (TKA) has shown excellent survival. However, some patients were up to 20%, they still had pain and make them dissatisfy after operation. The medial unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Patient Reported Outcome Measure
- What is being tested?
- Oxford UKA and Vanguard TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2017to 1 Dec 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anteromedial OA knee
Who cannot join
- varus deformity > 15 degrees
- ROM < 90 degrees
- fixed varus deformity
- post-traumatic arthritis
- inflammatory arthritis
- anterior cruciate ligament insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Orthopedics, Faculty of Medicine, Thammasat University
The total knee replacement (TKA) has shown excellent survival. However, some patients were up to 20%, they still had pain and make them dissatisfy after operation. The medial unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic compare to TKA. However, The previous studies did not include the same characteristic of patient in their studies. Therefor, UKA should be better than TKA. This study will compare TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage, restore knee stability and restore natural knee kinematic and biomechanic. Therefore, patients who underwent mobile bearing UKA will feel like normal knee and restore function to near or nearly normal. The measurement of clinical outcome after knee arthroplasty is questionable. The self-report questionnaire was used in the past. However, this score can not estimate the true function of patients. The patient have shown high score, but they still had pain and did not show satisfy after operation.The performance-based test such as 2-minute walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show the exactly clinical outcome of patient following knee arthroplasty compare to self-report questionnaire. Today, no randomized controlled trial study to compare performance-based test between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between TKA and mobile bearing UKA in medial OA knee.
Read the detailed description
The inclusion criteria were patients with medial of the knee with an Alhback score of 2, 3 or 4, those who were older than 40 years of age, those with a range of motion (ROM) > 90°, those with a varus deformity < 25°, and those with a flexion contracture < 20°. They were randomized into 2 groups using computer program. Group I was 50 UKAs and group II was 50 TKAs. All patients in group I received medial mobile-bearing UKA (Oxford® UKA; Zimmer Biomet, Inc, Warsaw, IN, USA) and group II received posterior stabilized fixed bearing total knee arthroplasty (Vanguard®; Zimmer Biomet, Inc, Warsaw, IN, USA). The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency or completely rupture of ACL, inflammatory joint disease, gout, posttraumatic arthritis, or primary patellofemoral arthritis.The recorded baseline patient characteristics included age and sex and the knee side, Knee Society Score (KSS), Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score (KOOS),(2MWT), (6MWT), (TUG), body mass index (BMI), degree of varus deformity, degree of flexion contracture, genu recurvatum, and ROM. Patients were followed at 6 weeks, 3 months, 6 months, and 1 year and then annually thereafter. At each follow-up, the following data were recorded: Joint Forgotten Score (JFS), KSS, OKS, Knee Injury and Osteoarthritis Outcome Score (KOOS), Kujala score, (2MWT), (TUG), ROM and knee alignment. In addition, the following knee X-rays were performed: anteroposterior (AP) and lateral standing, skyline and long-leg views; from these, the tibiofemoral angles were measured. Complications such as infection, component loosening, fractures, and bearing dislocations were also recorded. We determined differences in the KSS, OKS, KOOS, JFS, Kujala score,(2MWT), (TUG),ROM, tibiofemoral angle, flexion contractures, and genu recurvatum using Student's t tests. All analyses were two sided, and a p value of ≤ 0.05 denoted statistical significance.
- Conditions
- Patient Reported Outcome Measure
- Being tested
- Oxford UKA, Vanguard TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford UKADevice
knee arthroplasty
Vanguard TKADevice
knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Mobile bearing unicompartmental knee arthroplasty | Active comparator | 50 mobile bearing UKA Receives: Device: Oxford UKA |
| posterior stabilized fixed bearing total knee arthroplasty | Active comparator | 50 posterior stabilized fixed bearing cemented total knee arthroplasty Receives: Device: Vanguard TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 minutes walk test (2MWT)
measurement of endurance that assesses walking distance over 2 minutes
Measured: 2 years
time up and go test (TUG)
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: 2 years
Secondary outcomes (4)
Knee Society Score
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
Measured: 2 years
Oxford knee score
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
Measured: 2 years
Forgotten Joint Score
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
Measured: 2 years
Kujala score
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jun 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Reported Outcome MeasureStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
- Investigators
- Boonchana Pongcharoen, MD, Study director, faculty of medicine, Thammasat university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419129
- Sponsor's protocol ID
- ThmmasatU
- Status last verified
- Aug 2021
- First submitted
- 28 May 2017
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pongcharoen B, Liengwattanakol P, Boontanapibul K. Comparison of Functional Recovery Between Unicompartmental and Total Knee Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):191-201. doi: 10.2106/JBJS.21.00950. Epub 2022 Dec 21.
PubMed 36542689
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Orthopedics, Faculty of Medicine, Thammasat University
- ClinicalTrials.gov ID
- NCT04419129
- Acronym / sponsor ID
- ThmmasatU
- Conditions
- Patient Reported Outcome Measure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Jun 2020 (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.
The total knee replacement (TKA) has shown excellent survival. However, some patients were up to 20%, they still had pain and make them dissatisfy after operation. The medial unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic compare to TKA. However, The previous studies did not include the same characteristic of patient in their studies. Therefor, UKA should be better than TKA. This study will compare TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage, restore knee stability and restore natural knee kinematic and biomechanic. Therefore, patients who underwent mobile bearing UKA will feel like normal knee and restore function to near or nearly normal. The measurement of clinical outcome after knee arthroplasty is questionable. The self-report questionnaire was used in the past. However, this score can not estimate the true function of patients. The patient have shown high score, but they still had pain and did not show satisfy after operation.The performance-based test such as 2-minute walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show the exactly clinical outcome of patient following knee arthroplasty compare to self-report questionnaire. Today, no randomized controlled trial study to compare performance-based test between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between TKA and mobile bearing UKA in medial OA knee.
Detailed description
The inclusion criteria were patients with medial of the knee with an Alhback score of 2, 3 or 4, those who were older than 40 years of age, those with a range of motion (ROM) > 90°, those with a varus deformity < 25°, and those with a flexion contracture < 20°. They were randomized into 2 groups using computer program. Group I was 50 UKAs and group II was 50 TKAs. All patients in group I received medial mobile-bearing UKA (Oxford® UKA; Zimmer Biomet, Inc, Warsaw, IN, USA) and group II received posterior stabilized fixed bearing total knee arthroplasty (Vanguard®; Zimmer Biomet, Inc, Warsaw, IN, USA). The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency or completely rupture of ACL, inflammatory joint disease, gout, posttraumatic arthritis, or primary patellofemoral arthritis.The recorded baseline patient characteristics included age and sex and the knee side, Knee Society Score (KSS), Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score (KOOS),(2MWT), (6MWT), (TUG), body mass index (BMI), degree of varus deformity, degree of flexion contracture, genu recurvatum, and ROM. Patients were followed at 6 weeks, 3 months, 6 months, and 1 year and then annually thereafter. At each follow-up, the following data were recorded: Joint Forgotten Score (JFS), KSS, OKS, Knee Injury and Osteoarthritis Outcome Score (KOOS), Kujala score, (2MWT), (TUG), ROM and knee alignment. In addition, the following knee X-rays were performed: anteroposterior (AP) and lateral standing, skyline and long-leg views; from these, the tibiofemoral angles were measured. Complications such as infection, component loosening, fractures, and bearing dislocations were also recorded. We determined differences in the KSS, OKS, KOOS, JFS, Kujala score,(2MWT), (TUG),ROM, tibiofemoral angle, flexion contractures, and genu recurvatum using Student's t tests. All analyses were two sided, and a p value of ≤ 0.05 denoted statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile bearing unicompartmental knee arthroplasty | Active comparator | Device: Oxford UKA50 mobile bearing UKA |
| posterior stabilized fixed bearing total knee arthroplasty | Active comparator | Device: Vanguard TKA50 posterior stabilized fixed bearing cemented total knee arthroplasty |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anteromedial OA knee
Key exclusion criteria (6 listed)
- varus deformity > 15 degrees
- ROM < 90 degrees
- fixed varus deformity
- post-traumatic arthritis
- inflammatory arthritis
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 |
|---|---|---|
| Oxford UKAknee arthroplasty | Device | Mobile bearing unicompartmental knee arthroplasty |
| Vanguard TKAknee arthroplasty | Device | posterior stabilized fixed bearing total knee arthroplasty |
Primary outcome
2 minutes walk test (2MWT)
Time frame: 2 years
measurement of endurance that assesses walking distance over 2 minutes
time up and go test (TUG)
Time frame: 2 years
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
4 secondary outcomes
Knee Society Score
Time frame: 2 years
Oxford knee score
Time frame: 2 years
Forgotten Joint Score
Time frame: 2 years
Kujala score
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 36542689Pongcharoen B, Liengwattanakol P, Boontanapibul K. Comparison of Functional Recovery Between Unicompartmental and Total Knee Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):191-201. doi: 10.2106/JBJS.21.00950. Epub 2022 Dec 21.
- 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.
Boonchana Pongcharoen, MD study director
faculty of medicine, Thammasat university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford UKA and Vanguard TKA in people with Patient Reported Outcome Measure, run by Thammasat University at 1 site in Thailand.
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 6 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 31 Aug 2021. 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2 minutes walk test (2MWT) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT04419129, which also lists 1 linked publication.
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 31 Aug 2021.