Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures (MAPTIN)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Prof. Sajjad Hussain
- Número de teléfono: 0333 4077389
- Correo electrónico: prof.sajjadhussain@aimc.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Montiha Azeem
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- Jinnah Hospital Lahore
-
Contacto:
- Prof. Sajjad Hussain
- Número de teléfono: 0333 4077389
- Correo electrónico: prof.sajjadhussain@aimc.edu.pk
-
Contacto:
- Montiha Azeem
- Número de teléfono: 03479717317
-
Investigador principal:
- Prof. Sajjad Hussain
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: group A Medial Parapatellar Approach
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.
|
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.
|
|
Comparador activo: Transpatellar Approach
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lower Extremity Functional Scale (LEFS) Score
Periodo de tiempo: 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.
|
4 and 8 weeks after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Prof. Sajjad Hussain, AIMC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ERB195/4/06-11-2025/AIMC/JHL
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .