Tibial Shaft FractureELPPNCT07657559
RCT - Suprapatellar Approach Versus Lateral Parapatellar Approach in Tibial Shaft Fracture
A study testing suprapatellar approach and extra-articular lateral parapatellar approach in people with Tibial Shaft Fracture and Intramedullary Nail, run by Queen Savang Vadhana Memorial Hospital, Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tibial Shaft Fracture, Intramedullary Nail
- What is being tested?
- suprapatellar approach and extra-articular lateral parapatellar approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60 years
- tibial shaft fractures
Who cannot join
- pervious knee injury
- open fracture at least Gustilo grade II
- ipsilateral femur and ankle fractures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Suprapatellar Approach Versus Extra-articular Lateral Parapatellar Approach in Tibial Shaft Fractures: A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Tibial Shaft Fracture, Intramedullary Nail
- Being tested
- suprapatellar approach, extra-articular lateral parapatellar approach
- Keywords
- suprapatellar approach, extra-articular lateral parapatellar approach, intramedullary nailing, tibial shaft fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprapatellar approachProcedure or surgery
semi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint
extra-articular lateral parapatellar approachProcedure or surgery
semi-extended position longitudinal incision 4-5 cm., lateral to patellar tendon nail insertion procedure
| Study group | Role | What they receive |
|---|---|---|
| suprapatellar approach | Active comparator | Not described Receives: Procedure: suprapatellar approach |
| extra-articular lateral parapatellar approach | Experimental | Not described Receives: Procedure: extra-articular lateral parapatellar approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Knee Score
Measured: 6 months
Secondary outcomes (5)
operative time
Measured: operation
VAS score of knee
Measured: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
range of motion
knee
Measured: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
intraoperative blood loss
Measured: operation
fluoroscopy time
Measured: operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Shaft FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were divided into two groups using computer-generated block-of-four randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657559
- Sponsor's protocol ID
- 016/2567
- Acronym
- ELPP
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data was save in form of Microsoft excel spreadsheet and SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Suprapatellar Approach Versus Extra-articular Lateral Parapatellar Approach in Tibial Shaft Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07657559
- Acronym / sponsor ID
- ELPP / 016/2567
- Conditions
- Tibial Shaft Fracture, Intramedullary Nail
- Keywords
- suprapatellar approach, extra-articular lateral parapatellar approach, intramedullary nailing, tibial shaft fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patients were divided into two groups using computer-generated block-of-four randomization.
| Arm | Type | Receives |
|---|---|---|
| suprapatellar approach | Active comparator | Procedure: suprapatellar approach |
| extra-articular lateral parapatellar approach | Experimental | Procedure: extra-articular lateral parapatellar approach |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-60 years
- tibial shaft fractures
Key exclusion criteria (3 listed)
- pervious knee injury
- open fracture at least Gustilo grade II
- ipsilateral femur and ankle fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suprapatellar approachsemi-extended position longitudinal incision 2 cm. above patella nail insertion procedure under patellofemoral joint | Procedure or surgery | suprapatellar approach |
| extra-articular lateral parapatellar approachsemi-extended position longitudinal incision 4-5 cm., lateral to patellar tendon nail insertion procedure | Procedure or surgery | extra-articular lateral parapatellar approach |
Primary outcome
Lysholm Knee Score
Time frame: 6 months
5 secondary outcomes
operative time
Time frame: operation
VAS score of knee
Time frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
range of motion
Time frame: POD 1, 2 weeks, 6 weeks, 3 months, 6 months
intraoperative blood loss
Time frame: operation
fluoroscopy time
Time frame: operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. data was save in form of Microsoft excel spreadsheet and SPSS file
Related trials for Tibial Shaft Fracture
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Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
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Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing suprapatellar approach and extra-articular lateral parapatellar approach in people with Tibial Shaft Fracture and Intramedullary Nail, run by Queen Savang Vadhana Memorial Hospital, Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiwat Wongkasemjit M.D., Resident (+66893146833, toytiwat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.