Application of LARS Ligament in Bone Prosthesis Replacement

January 22, 2024 updated by: Wang Jiaqiang, Henan Cancer Hospital

A Prospective, Real-world, Single-center, Cohort Study of LARS Ligaments in Bone Tumors

This is a single-center, prospective, real-world observational study designed to enroll all patients eligible for enrollment. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center prospective real-world observational study of 100 eligible patients with bone tumors who are scheduled to undergo LARS ligament implantation and/or bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Department of Bone and Soft Tissue ,Henan Cancer Hospital
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing LARS ligament and bone prosthesis replacement

Description

Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received LARS ligament and bone prosthesis replacement at our hospital.

Exclusion Criteria:

Not Applicable.

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LARS ligament and bone prosthesis replacement was performed
To report the postoperative complications and limb function of patients who underwent LARS ligament and bone prosthesis replacement in Henan Cancer Hospital.
Other: LARS ligament and bone prosthesis replacement was performed
To report the postoperative complications and limb function of patients who underwent LARS ligament and bone prosthesis replacement in Henan Cancer Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: From surgery to 24 months after surgery
Complications of patients undergoing LARS ligament and bone prosthesis replacement.
From surgery to 24 months after surgery
Limb function
Time Frame: Patients were enrolled until 24 months after surgery
Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.
Patients were enrolled until 24 months after surgery

Collaborators and Investigators

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

Sponsor

Henan Cancer 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 (Estimated)

December 30, 2024

Primary Completion (Estimated)

February 28, 2032

Study Completion (Estimated)

February 28, 2032

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZZUSC-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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