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Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures

Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07761780
Acronym
MAPTIN
Enrollment
56
Registered
2026-08-12
Start date
2026-08-08
Completion date
2026-10-10
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Shaft Fractures

Keywords

Tibial shaft fracture, Intramedullary nailing, Medial parapatellar approach, Transpatellar approach

Brief 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. 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.

Interventions

PROCEDUREIntramedullary Nailing Using Medial Parapatellar Approach

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.

PROCEDUREIntramedullary Nailing Using Transpatellar Approach

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.

Sponsors

Allama Iqbal Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Lower Extremity Functional Scale (LEFS) Score4 and 8 weeks after surgeryFunctional 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.

Countries

Pakistan

Contacts

CONTACTProf. Sajjad Hussain
prof.sajjadhussain@aimc.edu.pk0333 4077389
CONTACTMontiha Azeem
PRINCIPAL_INVESTIGATORProf. Sajjad Hussain

AIMC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026