Tibial Shaft FracturesMAPTINNCT07761780
Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures
A study testing Intramedullary Nailing Using Medial Parapatellar Approach and Intramedullary Nailing Using Transpatellar Approach in people with Tibial Shaft Fractures, run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial summary
Tibial shaft fractures are breaks in the main part of the shin bone and commonly require surgery to restore alignment and allow the patient to return to normal activities. Intramedullary nailing is a commonly used surgical treatment for these fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tibial Shaft Fractures
- What is being tested?
- Intramedullary Nailing Using Medial Parapatellar Approach and Intramedullary Nailing Using Transpatellar Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Aug 2026to 10 Oct 2026
- 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
- Adults aged 18 to 60 years, irrespective of sex.
- Patients with an acute tibial shaft fracture confirmed by radiographic examination.
- Gustilo-Anderson type I, II, or IIIA open fractures.
- Patients who are eligible for intramedullary interlocking nailing according to the treating orthopedic surgeon.
- Patients willing and able to provide written informed consent.
Who cannot join
- Previous fracture or surgery involving the affected tibia.
- Osteoporosis or other conditions significantly affecting bone healing.
- Diabetes mellitus, peripheral vascular disease, autoimmune disorders, or other systemic conditions that may adversely affect bone healing or postoperative recovery.
- Neurovascular injury involving the affected limb.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Montiha Azeem contact
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital Lahore
Lahore, Punjab Province, 54000
Prof. Sajjad Hussain, 0333 4077389, prof.sajjadhussain@aimc.edu.pk
Montiha Azeem, 03479717317
About this study
Tibial shaft fractures are breaks in the main part of the shin bone and commonly require surgery to restore alignment and allow the patient to return to normal activities. Intramedullary nailing is a commonly used surgical treatment for these fractures. There are different surgical approaches that can be used to insert the nail, including the medial parapatellar approach and the transpatellar approach.
This study will compare these two surgical approaches to determine whether one is associated with better recovery after surgery. A total of 56 adults with acute tibial shaft fractures will participate in the study. Participants will be randomly assigned to receive intramedullary nailing through either the medial parapatellar approach or the transpatellar approach.
Read more
Recovery will be evaluated after surgery using measures of lower-limb function, pain, and knee movement. Lower-limb function will be assessed using the Lower Extremity Functional Scale (LEFS), pain will be assessed using the Numeric Pain Rating Scale (NPRS), and knee range of motion will be measured using a universal goniometer.
Participants will be assessed at 4 weeks and 8 weeks after surgery. The main outcome of the study will be functional recovery measured by the LEFS. The study will also compare postoperative pain and knee range of motion between the two surgical approaches.
The purpose of this study is to determine whether the medial parapatellar or transpatellar approach is associated with better early functional recovery following intramedullary nailing of tibial shaft fractures. The results may help orthopedic surgeons select the surgical approach that provides better postoperative recovery for patients with tibial shaft fractures.
Read the detailed description
Tibial shaft fractures are common long-bone injuries that frequently require operative fixation, particularly when the fracture is displaced or associated with significant soft-tissue injury. Intramedullary interlocking nailing is widely used because it provides stable fixation while allowing early mobilization and weight-bearing.
The surgical approach used to access the proximal tibia for intramedullary nail insertion may influence postoperative knee symptoms and functional recovery. The medial parapatellar and transpatellar approaches are commonly used techniques; however, previous comparative studies have reported inconsistent findings regarding postoperative pain, knee function, and range of motion.
This randomized controlled trial will compare functional recovery following intramedullary nailing of tibial shaft fractures using the medial parapatellar approach versus the transpatellar approach. Eligible participants will be randomly allocated in a 1:1 ratio to one of the two surgical approach groups.
Participants will undergo static interlocked intramedullary nailing performed by experienced orthopedic surgeons according to standardized operative and postoperative protocols. The surgical approach will be the primary difference between the two intervention groups.
The primary outcome will be functional recovery assessed using the Lower Extremity Functional Scale (LEFS). Secondary outcomes will include postoperative pain assessed using the Numeric Pain Rating Scale (NPRS) and knee range of motion assessed using a universal goniometer. Outcome assessments will be performed at 4 and 8 weeks after surgery.
Baseline demographic and clinical characteristics, including age, sex, body mass index, time from injury to surgery, and Gustilo-Anderson fracture classification, will also be recorded.
The study will include 56 participants, with 28 participants allocated to each treatment group. Participants will be adults aged 18 to 60 years with acute tibial shaft fractures meeting the predefined eligibility criteria.
The study will evaluate whether the choice of surgical approach is associated with differences in early postoperative functional recovery, pain, and knee mobility. The findings may provide comparative evidence to support surgical decision-making and postoperative rehabilitation following intramedullary nailing of tibial shaft fractures.
- Conditions
- Tibial Shaft Fractures
- Being tested
- Intramedullary Nailing Using Medial Parapatellar Approach, Intramedullary Nailing Using Transpatellar Approach
- Keywords
- Tibial shaft fracture, Intramedullary nailing, Medial parapatellar approach, Transpatellar approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary Nailing Using Medial Parapatellar ApproachProcedure or surgery
Intramedullary interlocking nailing of an acute tibial shaft fracture using the medial parapatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery.
Intramedullary Nailing Using Transpatellar ApproachProcedure or surgery
Intramedullary interlocking nailing of an acute tibial shaft fracture using the transpatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| group A Medial Parapatellar Approach | Experimental | Participants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the medial parapatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery. Receives: Procedure: Intramedullary Nailing Using Medial Parapatellar Approach |
| Transpatellar Approach | Active comparator | Participants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the transpatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery. Receives: Procedure: Intramedullary Nailing Using Transpatellar Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale (LEFS) Score
Functional recovery of the affected lower extremity will be assessed using the Lower Extremity Functional Scale (LEFS), a 20-item patient-reported outcome measure evaluating difficulty with physical activities and daily functional tasks. Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function. LEFS will be assessed at 4 and 8 weeks after surgery to compare functional recovery between the medial parapatellar and transpatellar approach groups.
Measured: 4 and 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start8 Aug 2026 (estimated)
- Primary completion8 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Shaft FracturesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sajjad Hussain Goraya, Allama Iqbal Medical College
- Investigators
- Prof. Sajjad Hussain, Principal investigator, AIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761780
- Sponsor's protocol ID
- ERB195/4/06-11-2025/AIMC/JHL
- Acronym
- MAPTIN
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures
- ClinicalTrials.gov ID
- NCT07761780
- Acronym / sponsor ID
- MAPTIN / ERB195/4/06-11-2025/AIMC/JHL
- Conditions
- Tibial Shaft Fractures
- Keywords
- Tibial shaft fracture, Intramedullary nailing, Medial parapatellar approach, Transpatellar approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- 8 Aug 2026 (estimated)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 12 Aug 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.
Tibial shaft fractures are breaks in the main part of the shin bone and commonly require surgery to restore alignment and allow the patient to return to normal activities. Intramedullary nailing is a commonly used surgical treatment for these fractures. There are different surgical approaches that can be used to insert the nail, including the medial parapatellar approach and the transpatellar approach.
This study will compare these two surgical approaches to determine whether one is associated with better recovery after surgery. A total of 56 adults with acute tibial shaft fractures will participate in the study. Participants will be randomly assigned to receive intramedullary nailing through either the medial parapatellar approach or the transpatellar approach.
Recovery will be evaluated after surgery using measures of lower-limb function, pain, and knee movement. Lower-limb function will be assessed using the Lower Extremity Functional Scale (LEFS), pain will be assessed using the Numeric Pain Rating Scale (NPRS), and knee range of motion will be measured using a universal goniometer.
Participants will be assessed at 4 weeks and 8 weeks after surgery. The main outcome of the study will be functional recovery measured by the LEFS. The study will also compare postoperative pain and knee range of motion between the two surgical approaches.
The purpose of this study is to determine whether the medial parapatellar or transpatellar approach is associated with better early functional recovery following intramedullary nailing of tibial shaft fractures. The results may help orthopedic surgeons select the surgical approach that provides better postoperative recovery for patients with tibial shaft fractures.
Detailed description
Tibial shaft fractures are common long-bone injuries that frequently require operative fixation, particularly when the fracture is displaced or associated with significant soft-tissue injury. Intramedullary interlocking nailing is widely used because it provides stable fixation while allowing early mobilization and weight-bearing.
The surgical approach used to access the proximal tibia for intramedullary nail insertion may influence postoperative knee symptoms and functional recovery. The medial parapatellar and transpatellar approaches are commonly used techniques; however, previous comparative studies have reported inconsistent findings regarding postoperative pain, knee function, and range of motion.
This randomized controlled trial will compare functional recovery following intramedullary nailing of tibial shaft fractures using the medial parapatellar approach versus the transpatellar approach. Eligible participants will be randomly allocated in a 1:1 ratio to one of the two surgical approach groups.
Participants will undergo static interlocked intramedullary nailing performed by experienced orthopedic surgeons according to standardized operative and postoperative protocols. The surgical approach will be the primary difference between the two intervention groups.
The primary outcome will be functional recovery assessed using the Lower Extremity Functional Scale (LEFS). Secondary outcomes will include postoperative pain assessed using the Numeric Pain Rating Scale (NPRS) and knee range of motion assessed using a universal goniometer. Outcome assessments will be performed at 4 and 8 weeks after surgery.
Baseline demographic and clinical characteristics, including age, sex, body mass index, time from injury to surgery, and Gustilo-Anderson fracture classification, will also be recorded.
The study will include 56 participants, with 28 participants allocated to each treatment group. Participants will be adults aged 18 to 60 years with acute tibial shaft fractures meeting the predefined eligibility criteria.
The study will evaluate whether the choice of surgical approach is associated with differences in early postoperative functional recovery, pain, and knee mobility. The findings may provide comparative evidence to support surgical decision-making and postoperative rehabilitation following intramedullary nailing of tibial shaft fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A Medial Parapatellar Approach | Experimental | Procedure: Intramedullary Nailing Using Medial Parapatellar ApproachParticipants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the medial parapatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery. |
| Transpatellar Approach | Active comparator | Procedure: Intramedullary Nailing Using Transpatellar ApproachParticipants allocated to this arm will undergo intramedullary interlocking nailing of the tibial shaft fracture using the transpatellar surgical approach for access to the tibial entry point. The procedure will be performed by experienced orthopedic surgeons according to the standardized operative and postoperative protocols of the study. Participants will receive routine postoperative care and rehabilitation according to the study protocol. Functional recovery, postoperative pain, and knee range of motion will be assessed at 4 and 8 weeks after surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 60 years, irrespective of sex.
- Patients with an acute tibial shaft fracture confirmed by radiographic examination.
- Gustilo-Anderson type I, II, or IIIA open fractures.
- Patients who are eligible for intramedullary interlocking nailing according to the treating orthopedic surgeon.
- Patients willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Previous fracture or surgery involving the affected tibia.
- Osteoporosis or other conditions significantly affecting bone healing.
- Diabetes mellitus, peripheral vascular disease, autoimmune disorders, or other systemic conditions that may adversely affect bone healing or postoperative recovery.
- Neurovascular injury involving the affected limb.
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 |
|---|---|---|
| Intramedullary Nailing Using Medial Parapatellar ApproachIntramedullary interlocking nailing of an acute tibial shaft fracture using the medial parapatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery. | Procedure or surgery | group A Medial Parapatellar Approach |
| Intramedullary Nailing Using Transpatellar ApproachIntramedullary interlocking nailing of an acute tibial shaft fracture using the transpatellar approach for access to the proximal tibial entry point. The procedure will be performed by experienced orthopedic surgeons using standardized operative and postoperative protocols. Participants will receive routine postoperative care and rehabilitation. The intervention will be evaluated for postoperative functional recovery, pain, and knee range of motion at 4 and 8 weeks after surgery. | Procedure or surgery | Transpatellar Approach |
Primary outcome
Lower Extremity Functional Scale (LEFS) Score
Time frame: 4 and 8 weeks after surgery
Functional recovery of the affected lower extremity will be assessed using the Lower Extremity Functional Scale (LEFS), a 20-item patient-reported outcome measure evaluating difficulty with physical activities and daily functional tasks. Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function. LEFS will be assessed at 4 and 8 weeks after surgery to compare functional recovery between the medial parapatellar and transpatellar approach groups.
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 14 Aug 2026.
Related trials for Tibial Shaft Fractures
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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.
Montiha Azeem contact
Prof. Sajjad Hussain principal investigator
AIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary Nailing Using Medial Parapatellar Approach and Intramedullary Nailing Using Transpatellar Approach in people with Tibial Shaft Fractures, run by Allama Iqbal Medical College 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
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 Prof. Sajjad Hussain (0333 4077389, prof.sajjadhussain@aimc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (LEFS) Score (time frame: 4 and 8 weeks after surgery). 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 14 Aug 2026.