Transverse Fracture of Shaft of TibiaNCT04958564

Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia

A study testing DCP in people with Transverse Fracture of Shaft of Tibia, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Transverse Fracture of Shaft of Tibia
What is being tested?: DCP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 sitePakistan
Study dates: 20 Jan 2019to 20 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Patients with closed transverse tibial fractures

Who cannot join

Patients unsuitable for surgical intervention

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Orthopaedics Department ,DHQ Teaching Hospital Hospital Sahiwal
Sahiwal, Punjab Province, 57000

Other trials in Pakistan

About this study

Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.

Read the detailed description

This study is a comparison of two devices used to teat transverse fractures of tibia and these include intra medullary rod popularly known as intra medullary nail and the second is a weight bearing device know as dynamic compression plate which is fixed with screws to diaphyseal segment of bone.

Conditions: Transverse Fracture of Shaft of Tibia
Being tested: DCP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DCPDevice
Also called Interlock nailing
1. Dynamic compression plating to compress the fracture
2. Intramedullary device to share the load.

Study groups in NCT04958564
Study group	Role	What they receive
group interlock	Active comparator	Intra medullary device used to treat tibial shaft fractures Receives: Device: DCP
group DCP (dynamic compression plate)	Active comparator	dynamic compression plate used to treat tibial shaft fractures Receives: Device: DCP

What is being measured

The primary outcome is the main question the study is designed to answer.

weight bearing
when patient started to fully bear weight on affected leg after intervention
Measured: 12 weeks

Secondary outcomes (1)

time of union
time for union during which three cortices of the bone seem united radiologically
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 201920 Jan 2020

First posted12 Jul 2021
Study start20 Jan 2019
Primary completion20 Jan 2020
Study completion20 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Transverse Fracture of Shaft of TibiaStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04958564
Sponsor's protocol ID: DHQTHS
Status last verified: Jul 2021
First submitted: 25 Jun 2021
Last updated: 12 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: All data will probably be shared to fellow researchers after publication of study .

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia
ClinicalTrials.gov ID: NCT04958564
Acronym / sponsor ID: DHQTHS
Conditions: Transverse Fracture of Shaft of Tibia
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: District Headquarters Teaching Hospital SahiwalUniversity, hospital or other
Study start: 20 Jan 2019 (actual)
Primary completion: 20 Jan 2020 (actual)
Study completion: 20 Jan 2020 (actual)
First posted: 12 Jul 2021 (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.

Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
group interlock	Active comparator	Device: DCPIntra medullary device used to treat tibial shaft fractures
group DCP (dynamic compression plate)	Active comparator	Device: DCPdynamic compression plate used to treat tibial shaft fractures

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients with closed transverse tibial fractures

Key exclusion criteria (1 listed)

Patients unsuitable for surgical intervention

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
DCPAlso: Interlock nailing1. Dynamic compression plating to compress the fracture 2. Intramedullary device to share the load.	Device	group DCP (dynamic compression plate), group interlock

Primary outcome

weight bearing
Time frame: 12 weeks
when patient started to fully bear weight on affected leg after intervention

1 secondary outcome

time of union
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Individual participant dataSharing planned: Undecided. All data will probably be shared to fellow researchers after publication of study .

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. This study is not recruiting at the moment.

Humayun Israr, MBBS principal investigator

District Headquarters Teaching Hospital Sahiwal

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DCP in people with Transverse Fracture of Shaft of Tibia, run by District Headquarters Teaching Hospital Sahiwal at 1 site in Pakistan.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight bearing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04958564.

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 12 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.