NCT07657559

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Expected
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 14, 2026

Last Update Submit

June 14, 2026

Conditions

Tibial Shaft FractureIntramedullary Nail

Keywords

suprapatellar approachextra-articular lateral parapatellar approachintramedullary nailingtibial shaft fracture

Outcome Measures

Primary Outcomes (1)

  • Lysholm Knee Score

    6 months

Secondary Outcomes (5)

  • operative time

    operation

  • VAS score of knee

    POD 1, 2 weeks, 6 weeks, 3 months, 6 months

  • range of motion

    POD 1, 2 weeks, 6 weeks, 3 months, 6 months

  • intraoperative blood loss

    operation

  • fluoroscopy time

    operation

Study Arms (2)

suprapatellar approach

ACTIVE COMPARATOR
Procedure: suprapatellar approach

extra-articular lateral parapatellar approach

EXPERIMENTAL
Procedure: extra-articular lateral parapatellar approach

Interventions

suprapatellar approachPROCEDURE

semi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint

suprapatellar approach
extra-articular lateral parapatellar approachPROCEDURE

semi-extended position longitudinal incision 4-5 cm., lateral to patellar tendon nail insertion procedure

extra-articular lateral parapatellar approach

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60 years
  • tibial shaft fractures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Tiwat Wongkasemjit M.D., Resident

CONTACT

+66893146833toytiwat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients were divided into two groups using computer-generated block-of-four randomization.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

August 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

August 31, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06