Osteoarthritis, KneeNCT03358381
The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
A study testing the gap balance type of total knee arthroplasty and the measured resection type of total knee arthroplasty in people with Osteoarthritis, Knee, run by Peking University People's Hospital.
Trial summary
Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- the gap balance type of total knee arthroplasty and the measured resection type of total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications
Who cannot join
- There are surgical contraindications Varus or valgus alignment exceeds 20 degrees
Trial locations and contacts
No sites are listed yet.
About this study
Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.
Read the detailed description
This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.
- Conditions
- Osteoarthritis, Knee
- Being tested
- the gap balance type of total knee arthroplasty, the measured resection type of total knee arthroplasty
- Keywords
- total knee arthroplasty, CT scan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the gap balance type of total knee arthroplastyProcedure or surgery
A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.
the measured resection type of total knee arthroplastyProcedure or surgery
A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.
| Study group | Role | What they receive |
|---|---|---|
| gap balance group | Experimental | The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed. Receives: Procedure: the gap balance type of total knee arthroplasty |
| measured resection group | Active comparator | The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed. Receives: Procedure: the measured resection type of total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
femoral component rotation
The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.
Measured: 6 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chenyifan, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, arthritis clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358381
- Sponsor's protocol ID
- PKUPHJSL
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
- ClinicalTrials.gov ID
- NCT03358381
- Acronym / sponsor ID
- PKUPHJSL
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee arthroplasty, CT scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 30 Nov 2017 (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.
Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.
Detailed description
This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gap balance group | Experimental | Procedure: the gap balance type of total knee arthroplastyThe type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed. |
| measured resection group | Active comparator | Procedure: the measured resection type of total knee arthroplastyThe type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications
Key exclusion criteria (1 listed)
- There are surgical contraindications Varus or valgus alignment exceeds 20 degrees
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 |
|---|---|---|
| the gap balance type of total knee arthroplastyA gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention. | Procedure or surgery | gap balance group |
| the measured resection type of total knee arthroplastyA measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention. | Procedure or surgery | measured resection group |
Primary outcome
femoral component rotation
Time frame: 6 weeks after the surgery
The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jianhao Lin, MD principal investigator
arthritis clinic and research center
Questions about this trial
What is this clinical trial studying?
A study testing the gap balance type of total knee arthroplasty and the measured resection type of total knee arthroplasty in people with Osteoarthritis, Knee, run by Peking University People's Hospital.
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: status not confirmed, as of the sponsor's last update on 30 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leyuan Chen (18600116051, chenleyuanqia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
femoral component rotation (time frame: 6 weeks after the surgery). 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 30 Nov 2017.