RCT - Suprapatellar Approach Versus Lateral Parapatellar... | NCT07657559

Studies
RCT - Suprapatellar Approach Versus Lateral Parapatellar Approach in Tibial Shaft Fracture

NCT07657559

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Not yet recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Tibial Shaft Fracture
Intramedullary Nail

Interventions

suprapatellar approach
extra-articular lateral parapatellar approach

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

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 31, 2028Estimated

First Submitted Date

Jun 14, 2026

First Submission Date that Met QC Criteria

Jun 14, 2026

First Posted Date

Jun 18, 2026Actual

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

Jun 14, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 study aims to compare 2 surgical techniques for tibial shaft nailing (suprapatellar approach vs extra-articular lateral parapatellar approach). following peri-operative and postoperative outcomes

Detailed Description

This is a randomized controlled trial study, compared extra-articular lateral parapatellar approach with suprapatellar approach in tibial shaft nailing. peri-operative data are operative time, blood loss, fluoroscopy time, hospital stay. post-operative outcomes include Lysholm Knee Score, VAS-knee, range of motion. these outcomes are following postoperative day 1, 2 weeks, 6 weeks, 3 months and 6 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suprapatellar approach	Active Comparator		Procedure: suprapatellar approach
extra-articular lateral parapatellar approach	Experimental		Procedure: extra-articular lateral parapatellar approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
suprapatellar approach	Procedure	semi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint	suprapatellar approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lysholm Knee Score		6 months

Secondary Outcomes

Measure	Description	Time Frame
operative time		operation
VAS score of knee		POD 1, 2 weeks, 6 weeks, 3 months, 6 months
range of motion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-60 years
tibial shaft fractures

Exclusion Criteria:

pervious knee injury
open fracture at least Gustilo grade II
ipsilateral femur and ankle fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tiwat Wongkasemjit M.D., Resident	Contact	+66893146833		toytiwat@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

data was save in form of Microsoft excel spreadsheet and SPSS file

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided