China Medical University Hospital
Taichung, North District, 404327, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT05685706
Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Primary outcomes
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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).
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
China Medical University Hospital
Other
Registry information
Important dates
- Study start
- 2021
- Primary completion
- 2031
- Study completion
- 2031
- First posted
- Jan 17, 2023
- Registry last updated
- Jan 17, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.