Cases Who Received TKA/THANCT05685706
Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty
An observational study of Cases Who Received TKA/THA, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cases Who Received TKA/THA
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2021to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration patients who take Total hip and knee arthroplasty
Who may be able to join
- Primary degenerative arthritis of the knee or hip
- Those who have undergone artificial knee or hip replacement surgery
- Follow up surgery for at least 1 year
- Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery
Who cannot join
- Previous hip surgery
- Previous spine surgery
- Contracture after hip fusion surgery
- Scoliosis over 10 degrees combined with neuropathy
- Patients with flexion contracture after knee joint surgery
- Rheumatoid arthritis lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, North District, 404327
Chun-Hao Tsai, PhD, 04-22052121 ext. 5052, ritsai8615@gmail.com
Yu-Han Chang, +886 0909 507 981, arthrokneecmuh@gmail.com
About this study
Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis.
Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.
- Conditions
- Cases Who Received TKA/THA
- Keywords
- Total hip/knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
The Forgotten Joint Score-12 (FJS-12)
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities (Rosinsky et al., 2019).
Measured: Post-operative at 24th month
EQ-5D
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.
Measured: Post-operative at 24th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start7 Jul 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cases Who Received TKA/THAStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685706
- Sponsor's protocol ID
- CMUH110-REC2-030
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05685706
- Acronym / sponsor ID
- CMUH110-REC2-030
- Conditions
- Cases Who Received TKA/THA
- Keywords
- Total hip/knee arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Jan 2023 (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.
Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis.
Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration patients who take Total hip and knee arthroplasty
Key inclusion criteria (4 listed)
- Primary degenerative arthritis of the knee or hip
- Those who have undergone artificial knee or hip replacement surgery
- Follow up surgery for at least 1 year
- Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery
Key exclusion criteria (6 listed)
- Previous hip surgery
- Previous spine surgery
- Contracture after hip fusion surgery
- Scoliosis over 10 degrees combined with neuropathy
- Patients with flexion contracture after knee joint surgery
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
The Forgotten Joint Score-12 (FJS-12)
Time frame: Post-operative at 24th month
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities (Rosinsky et al., 2019).
EQ-5D
Time frame: Post-operative at 24th month
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cases Who Received TKA/THA, run by China Medical University Hospital at 1 site in Taiwan.
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 4 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: looking for participants now, as of the sponsor's last update on 17 Jan 2023. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Hao Tsai, PhD (04-22052121 ext. 5052, ritsai8615@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Forgotten Joint Score-12 (FJS-12) (time frame: Post-operative at 24th month). 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?
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 17 Jan 2023.