Knee OsteoarthritisNCT04419116
Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA
A study testing tibial preservation bone cut in people with Knee Osteoarthritis and Knee Arthropathy, run by Thammasat University at 1 site in Thailand.
Trial summary
The mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. However, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthropathy
- What is being tested?
- tibial preservation bone cut
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2018to 1 Nov 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medial osteoarthritis of knee
Who cannot join
- posttraumatic arthritis
- gout
- Rheumatoid arthritis
- anterior cruciate ligament insufficiency
- osteonecrosis of knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faculty of Medicine, Thammasat University
The mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. However, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. The medial knee pain after operation was the one cause of revision. The incidence of medial knee pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local inflammation, over hanging of the tibial component and overstretching of the MCL due to the application of excessive polyethylene. Therefore, the tibia in this study was cut with under resection technique for reducing the overloading on the medial tibial plateau. The purpose of this study is to compare medial knee pain between tibial bone cut preservation technique and conventional tibial bone cut technique following mobile bearing UKA.
Read the detailed description
A randomized control trial study was conducted at Thammasat University hospital, Thailand. The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement (ROM) > 90°, a varus deformity < 25°, and flexion contracture < 20° who underwent a medial mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency, inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The patients were randomized with computer technique into 2 groups, group (gp) I, conventional tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score, pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months, 6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain were assessed in a blinded fashion by a research assistant at each visit using VAS scale (0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.
- Conditions
- Knee Osteoarthritis, Knee Arthropathy
- Being tested
- tibial preservation bone cut
- Keywords
- mobile bearing UKA, Oxford UKA, medial knee pain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tibial preservation bone cutProcedure or surgery
tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.
| Study group | Role | What they receive |
|---|---|---|
| tibial preservation bone cut | Experimental | tibial preservation bone cut following mobile bearing UKA Receives: Procedure: tibial preservation bone cut |
| tibial conventional bone cut | Experimental | tibial conventional bone cut following mobilebearing UKA Receives: Procedure: tibial preservation bone cut |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) for pain
pain at medial tibial plateau
Measured: 2 years
Secondary outcomes (5)
knee society score
The standard knee score for determining function after knee arthroplasty
Measured: 2 years
Oxford knee score
The standard knee score for determining function after knee arthroplasty
Measured: 2 years
joint forgotten score
The standard knee score for determining function after knee arthroplasty
Measured: 2 years
knee injury osteoarthritis outcome score
The standard knee score for determining function after knee arthroplasty
Measured: 2 years
Kujala score
The standard knee score for determining function after 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 2018
- Primary completion1 Aug 2021
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
- Investigators
- Boonchana Pongcharoen, Study director, faculty of medicine, Thammasat university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419116
- Sponsor's protocol ID
- MTU-EC-OT-1-137/62
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Faculty of Medicine, Thammasat University
- ClinicalTrials.gov ID
- NCT04419116
- Acronym / sponsor ID
- MTU-EC-OT-1-137/62
- Conditions
- Knee Osteoarthritis, Knee Arthropathy
- Keywords
- mobile bearing UKA, Oxford UKA, medial knee pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- 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 mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. However, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. The medial knee pain after operation was the one cause of revision. The incidence of medial knee pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local inflammation, over hanging of the tibial component and overstretching of the MCL due to the application of excessive polyethylene. Therefore, the tibia in this study was cut with under resection technique for reducing the overloading on the medial tibial plateau. The purpose of this study is to compare medial knee pain between tibial bone cut preservation technique and conventional tibial bone cut technique following mobile bearing UKA.
Detailed description
A randomized control trial study was conducted at Thammasat University hospital, Thailand. The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement (ROM) > 90°, a varus deformity < 25°, and flexion contracture < 20° who underwent a medial mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency, inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The patients were randomized with computer technique into 2 groups, group (gp) I, conventional tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score, pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months, 6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain were assessed in a blinded fashion by a research assistant at each visit using VAS scale (0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tibial preservation bone cut | Experimental | Procedure: tibial preservation bone cuttibial preservation bone cut following mobile bearing UKA |
| tibial conventional bone cut | Experimental | Procedure: tibial preservation bone cuttibial conventional bone cut following mobilebearing UKA |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medial osteoarthritis of knee
Key exclusion criteria (5 listed)
- posttraumatic arthritis
- gout
- Rheumatoid arthritis
- anterior cruciate ligament insufficiency
- osteonecrosis of knee
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 |
|---|---|---|
| tibial preservation bone cuttibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm. | Procedure or surgery | tibial conventional bone cut, tibial preservation bone cut |
Primary outcome
visual analog scale (VAS) for pain
Time frame: 2 years
pain at medial tibial plateau
5 secondary outcomes
knee society score
Time frame: 2 years
Oxford knee score
Time frame: 2 years
joint forgotten score
Time frame: 2 years
knee injury osteoarthritis outcome score
Time frame: 2 years
Kujala score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- 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 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 tibial preservation bone cut in people with Knee Osteoarthritis and Knee Arthropathy, 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 5 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: status not confirmed, 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?
Results are not available in the source record.
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?
visual analog scale (VAS) for pain (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 31 Aug 2021.