Intraoperative Measurement Technique | NCT06173557

Studies
Intraoperative Measurement Technique

NCT06173557

Sponsor

Ziv Medical Center

Status

Completed

Last Update Posted

Dec 15, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Total Hip
Limb Length Discrepancy

Interventions

entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic i

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
0025-15-ziv	Registry Identifier	ZivMC

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2015Actual

Primary Completion Date

Mar 20, 2017Actual

Completion Date

Jun 20, 2017Actual

First Submitted Date

Nov 28, 2023

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.

Detailed Description

Introduction: Restoration of limb length equality and femoral offset is critical for the success of THR. The purpose of this study was to investigate the efficacy of a novel intraoperative measurement technique in minimizing errors in leg length and offset in total hip replacement (THR).

Methods: This retrospective cohort study included 50 consecutive patients who underwent THR. All surgeries were performed by the same orthopedic surgeon, using posterior approach. In all patients, the same technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic i	Procedure	technique of intraoperative measurement of the femoral offset and limb length was used, entailed calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver. Measurements were collected from radiographic imaging data and surgical reports

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
outcome	calculation of the distances between reference points on the ischium, greater trochanter, and the screwdriver	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

* patients that underwent THR due to primary osteoarthritis of the hip joint.

Exclusion Criteria:

Patients who underwent THR for any other reasons
patients that underwent revision surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

50 consecutive patients who were admitted to the orthopedic department for elective THR

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

no sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided