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

January 12, 2023 updated by: China Medical University Hospital

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • North District
      • Taichung, North District, Taiwan, 404327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration patients who take Total hip and knee arthroplasty

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Post-operative at 24th month
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.
Post-operative at 24th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Anticipated)

December 31, 2031

Study Completion (Anticipated)

December 31, 2031

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH110-REC2-030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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