Total Knee ReplacementNCT02817737
Pre-operative Radiological Measurement to Assess Femur Rotational Alignment
An observational study of Total Knee Replacement, run by Xi'an Honghui Hospital at 2 sites in China.
Trial summary
Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty. Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Total Knee Replacement
- How many people
- 33 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2016to Oct 2016
- Phase
- Observational
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese female patients with primary varus knee OA, scheduled for primary TKAs
Who may be able to join
- Osteoarthritis Varus knee deformity
Who cannot join
- Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hong-hui Hospital
Xi'an
Qiang He, MD, 02983860818
- Recruiting
Honghui Hospital
Xi’an, Shanxi, 710054
Qiang He, MD, 02983860818, heqianghonghui@163.com
About this study
Official title: Pre-operative Radiological Measurement of Proximal Tibia Angle to Assess Femur Rotational Alignment in Total Knee Arthroplasty
Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.
Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). The CTA, angle between clinical transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the PTA was analyzed statistically with the linear regression.
- Conditions
- Total Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CT | Measured with computed tomography | |
| plain Radiography | Measured with plain Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
proximal tibia angle (PTA)
The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line.
Measured: Four months
Secondary outcomes (1)
Condylar twist angle (CTA)
The CTA is the angle between clinical transepicondylar axis and posterior condylar line
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Honghui Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianbing Ma, MD, Study director, Honghui Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817737
- Sponsor's protocol ID
- XianHongHuiH
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
Publications
Kanekasu K, Kondo M, Kadoya Y. Axial radiography of the distal femur to assess rotational alignment in total knee arthroplasty. Clin Orthop Relat Res. 2005 May;(434):193-7. doi: 10.1097/01.blo.0000156819.24866.8b.
PubMed 15864052Savin L, Botez P, Mihailescu D, Predescu V, Grierosu C. Pre-operative radiological measurement of femoral rotation for prosthetic positioning in total knee arthroplasty. Int Orthop. 2016 Sep;40(9):1855-60. doi: 10.1007/s00264-015-3110-2. Epub 2016 Jan 23.
PubMed 26803321Kobayashi H, Aratake M, Akamatsu Y, Mitsugi N, Taki N, Saito T. Reproducibility of condylar twist angle measurement using computed tomography and axial radiography of the distal femur. Orthop Traumatol Surg Res. 2014 Dec;100(8):885-90. doi: 10.1016/j.otsr.2014.07.025. Epub 2014 Nov 20.
PubMed 25453922
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Radiological Measurement of Proximal Tibia Angle to Assess Femur Rotational Alignment in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02817737
- Acronym / sponsor ID
- XianHongHuiH
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Xi'an Honghui HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 29 Jun 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.
Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.
Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). The CTA, angle between clinical transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the PTA was analyzed statistically with the linear regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT | – | –Measured with computed tomography |
| plain Radiography | – | –Measured with plain Radiography |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese female patients with primary varus knee OA, scheduled for primary TKAs
Key inclusion criteria (1 listed)
- Osteoarthritis Varus knee deformity
Key exclusion criteria (1 listed)
- Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proximal tibia angle (PTA)
Time frame: Four months
The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line.
1 secondary outcome
Condylar twist angle (CTA)
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 15864052Kanekasu K, Kondo M, Kadoya Y. Axial radiography of the distal femur to assess rotational alignment in total knee arthroplasty. Clin Orthop Relat Res. 2005 May;(434):193-7. doi: 10.1097/01.blo.0000156819.24866.8b.
- Background: PubMed 26803321Savin L, Botez P, Mihailescu D, Predescu V, Grierosu C. Pre-operative radiological measurement of femoral rotation for prosthetic positioning in total knee arthroplasty. Int Orthop. 2016 Sep;40(9):1855-60. doi: 10.1007/s00264-015-3110-2. Epub 2016 Jan 23.
- Background: PubMed 25453922Kobayashi H, Aratake M, Akamatsu Y, Mitsugi N, Taki N, Saito T. Reproducibility of condylar twist angle measurement using computed tomography and axial radiography of the distal femur. Orthop Traumatol Surg Res. 2014 Dec;100(8):885-90. doi: 10.1016/j.otsr.2014.07.025. Epub 2014 Nov 20.
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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.
Jianbing Ma, MD study director
Honghui Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Xi'an Honghui Hospital at 2 sites in China.
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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Contact Qiang He, MD (13572887175, heqianghonghui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proximal tibia angle (PTA) (time frame: Four months). 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 NCT02817737, which also lists 3 linked publications.
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 29 Jun 2016.