Criteria-based Rehabilitation After Tibial Fracture Fixation
Official title: Effectiveness of a Criteria-Based Progressive Loading and Functional Rehabilitation Program Compared With Usual Physiotherapy Following Surgical Fixation of Traumatic Tibial Fractures: A Randomized Controlled Trial
Run by Al-Azhar University · NCT07810478 · Data updated 2026-11-12
This trial tests a structured, criteria-driven rehabilitation plan against usual physiotherapy after tibial fracture surgery to see if it improves leg function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Gaza, Gaza Strip) |
| Status | Recruiting |
| Started | September 18, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07810478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a traumatic unilateral tibial fracture treated with surgical fixation, 2-8 weeks post-surgery, medically cleared for physiotherapy, and with a documented weight-bearing plan.
✕Probably not a fit
Patients whose recovery is limited by non-reconstructable damage, infection, or contraindications to rehabilitation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with surgically fixed tibial fractures in Gaza are randomly assigned to either a 6-8 week program guided by clinical and functional criteria or to standard physiotherapy. The intervention includes 2-3 supervised sessions per week plus home exercises, with progression only allowed when predefined criteria are met and weight-bearing limits are respected. Primary outcome is lower-extremity function measured by LEFS, with secondary outcomes on mobility, walking endurance, pain, range of motion, ambulation, aids use, and adverse events, assessed at baseline, post-intervention, and follow-up. The approach aims to determine if a standardized, criteria-based rehabilitation improves functional recovery after tibial fracture fixation.
Why it matters
Potential benefit: If successful, patients may regain walking ability and daily function more quickly and safely.
How similar studies have gone: Previous rehabilitation studies suggest that structured, progressive loading can improve outcomes after lower-limb fractures, but this specific criteria-based approach is being tested in Gaza for this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age ≥18 years. * Traumatic unilateral tibial fracture involving the proximal tibia/tibial plateau, tibial shaft, or distal tibia. * Treated with surgical fixation. * Recruitment 2-8 weeks after the index fixation surgery. * Medically and surgically stable and cleared by the treating team to participate in physiotherapy. * Documented postoperative weight-bearing status/instructions from the treating orthopedic team. * Able to participate in the study rehabilitation and complete the planned functional assessments when permitted by weight-bearing status. * Able to understand study instructions and provide written informed consent. * Open fractures are eligible provided the wound is clinically stable, there is no active uncontrolled infection preventing rehabilitation, and rehabilitation has been authorized by the treating surgical team. Exclusion criteria: * Pathological fracture. * Unstable fixation, fixation failure, or any orthopedic/medical contraindication to progressive rehabilitation. * Active or uncontrolled infection requiring restriction or interruption of rehabilitation. * Lower-limb amputation affecting functional assessment. * Spinal cord injury or severe traumatic brain injury affecting mobility or ability to participate. * Pre-existing neurological disorder substantially affecting gait or lower-limb function. * Major concomitant injury to either lower limb that substantially limits walking or participation in the rehabilitation protocol. * Severe cognitive impairment preventing understanding of instructions, valid outcome assessment, or informed consent. * Any medical condition considered by the treating physician to make participation in the rehabilitation program unsafe.
Where it's running
-
Mohammed Matar
Gaza, Gaza Strip, Palestinian Territories Recruiting
Study contacts
- Study coordinator: Mosab M Aldabbas, PhD
- Email: mosab.m.aldabbas@gmail.com
- Phone: 00972597451222
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Elastic nailing with Kirschner wires versus plate fixation for distal tibial fractures in adolescents
This trial tests whether elastic stable intramedullary nailing with Kirschner wires works as well as plate fixation for fixing distal tibial fractures in kids aged 10 to 16.
-
Verus frame in tibial nailing for precise alignment
This PMCF study tests whether the Verus frame helps surgeons get the tibia aligned and rotated correctly during suprapatellar tibial nailing in adults with tibial fractures.
-
Comparing the standard tibial intramedullary nail with a micromotion tibial nail for unstable tibial fractures.
This trial will test whether a micromotion tibial nail helps adults with unstable tibial fractures heal faster and have fewer complications than a standard tibial nail.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.