Primary GonarthrosisNCT02854189
The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum
A study testing Oxford unicompartmental knee arthroplasty in people with Primary Gonarthrosis and Genu Recurvatum, run by Thammasat University.
Trial summary
The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Primary Gonarthrosis, Genu Recurvatum
- What is being tested?
- Oxford unicompartmental knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2015
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°
Who cannot join
- patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.
About this study
Official title: Department of Orthopaedics Faculty of Medicine Thammasat University Thailand
The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared.
Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..
Read the detailed description
The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.
- Conditions
- Primary Gonarthrosis, Genu Recurvatum
- Being tested
- Oxford unicompartmental knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford unicompartmental knee arthroplastyDevice
The Oxford unicompartmental knee arthroplasty was applied in all patients with medial osteoarthritis knee.The Oxford unicompartmental knee arthroplasty is mobile bearing unicompartmental knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| patients with genu recurvatum | Other | The medial osteoarthritis knees with genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded. Receives: Device: Oxford unicompartmental knee arthroplasty |
| patients without genu recurvatum | Other | The medial osteoarthritis knees without genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded. Receives: Device: Oxford unicompartmental knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperextension angle, the incidence of postoperative genu recurvatum
hyperextension angle, the incidence of postoperative genu recurvatum
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 posted3 Aug 2016 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary GonarthrosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854189
- Sponsor's protocol ID
- MTU-EC-OT-0-051/59
- Status last verified
- Jul 2016
- First submitted
- 6 Jun 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Orthopaedics Faculty of Medicine Thammasat University Thailand
- ClinicalTrials.gov ID
- NCT02854189
- Acronym / sponsor ID
- MTU-EC-OT-0-051/59
- Conditions
- Primary Gonarthrosis, Genu Recurvatum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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 purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared.
Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..
Detailed description
The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with genu recurvatum | Other | Device: Oxford unicompartmental knee arthroplastyThe medial osteoarthritis knees with genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded. |
| patients without genu recurvatum | Other | Device: Oxford unicompartmental knee arthroplastyThe medial osteoarthritis knees without genu recurvatum were included in this study. Patients had been treated with cemented minimally invasive surgery Oxford unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up.The incidence of postoperative genu recurvatum, postoperative hyperextension angle, and the knee society score were recorded. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°
Key exclusion criteria (1 listed)
- patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.
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 unicompartmental knee arthroplastyThe Oxford unicompartmental knee arthroplasty was applied in all patients with medial osteoarthritis knee.The Oxford unicompartmental knee arthroplasty is mobile bearing unicompartmental knee arthroplasty. | Device | patients with genu recurvatum, patients without genu recurvatum |
Primary outcome
hyperextension angle, the incidence of postoperative genu recurvatum
Time frame: 2 years
hyperextension angle, the incidence of postoperative genu recurvatum
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 4 Jun 2020.
- 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.
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 Oxford unicompartmental knee arthroplasty in people with Primary Gonarthrosis and Genu Recurvatum, run by Thammasat University.
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 1 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 4 Jun 2020. 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 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?
hyperextension angle, the incidence of postoperative genu recurvatum (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 4 Jun 2020.