Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty

Recruiting

• Conditions: Cases Who Received TKA/THA

• Registration Number: NCT05685706
• Lead Sponsor: China Medical University Hospital

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Study First Submitted: 2022-12-29
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Primary degenerative arthritis of the knee or hip
2. Those who have undergone artificial knee or hip replacement surgery
3. Follow up surgery for at least 1 year
4. Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery

Exclusion Criteria

1. Previous hip surgery
2. Previous spine surgery
3. Contracture after hip fusion surgery
4. Scoliosis over 10 degrees combined with neuropathy
5. Patients with flexion contracture after knee joint surgery
6. Rheumatoid arthritis lesions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Forgotten Joint Score-12 (FJS-12)	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	Post-operative at 24th month	EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, North District, Taiwan