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Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05502679
Enrollment
56
Registered
2022-08-16
Start date
2022-09-01
Completion date
2024-07-20
Last updated
2024-08-20

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

Conditions

Fracture of Tibia Proximal Plateau

Keywords

rehabilitation, radiography, physical therapy, intra-articular knee fracture

Brief summary

Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following surgical fixation. No study to date has investigated the effect of standardized pragmatic exercise protocol added to immediate weight bearing after tibial plateau fractures surgical fixation on patient's functional outcomes, knee ROM, pain, radiographic boney alignment, gait, and return to work.

Detailed description

Tibial plateau fractures can permanently affect patients' quality of life, including significant socio-economic impact due to time off work, compromised knee functional integrity, secondary knee osteoarthritis, knee flexion contractures, job loss due to functional limitations, and limited ability to return to pre-injury level of sports participation. Additionally, patients with tibial plateau fracture are at greater risk of death compared to an age- and the gender-matched reference population. In orthopedics, weight-bearing refers to how much weight a person bears through an injured body part. During a single-leg stance, a person with no physical limitations will carry 100% of their body weight through each leg. Thus, grades of weight bearing are generally expressed as a percent of the body weight. Weight-bearing grades include (1) Non-weight bearing (NWB), which means the patient is not to put any weight through the affected limb(s); (2) Toe touch weight bearing (TTWB), which is poorly defined in the literature. In clinical practice, it is commonly described as having the ability to touch the toes to the floor without supporting weight from the affected limb. The pressure should be light enough to avoid crushing a potato crisp underfoot. Partial weight bearing (PWB) can range from anything greater than non-weight bearing to anything less than full weight bearing. The status is usually accompanied by a percentage figure to describe the extent of recommended weight bearing further. Most of the definitions in the literature define partial weight bearing as being 30% to 50% of a patient's body weight. Full weight bearing (FWB) means no restriction to weight bearing. In other words, 100% of a person's body weight can be transmitted through the designated limb. This term is somewhat interchangeable with the term 'weight bear as tolerated (WBAT), which allows them to self-limit their weight bearing up to full body weight. Restriction in weight bearing of the operated leg during standing and walking is needed to avoid complications during the postoperative recovery such as mal-union, fracture reduction loss, or hardware failure. Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time, while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following fixation. Early weight-bearing and early range of motion (ROM) for cartilage nourishment and preservation after selected lower limb surgical procedures are associated with positive postoperative outcomes, including decreased mortality and morbidity rate, functional improvements, reduced inpatient length of stay, and improved healing process. Early weight-bearing prescription, however, has to be carefully assessed, as it may result in fracture reduction loss, hardware failure, infection, malunion, or nonunion. The effectiveness of immediate partial post-operative weight-bearing in the management of lateral tibial plateau fractures resulted in favorable outcomes after immediate partial weight-bearing of 15 kg in cases of bicondylar tibial plateau fractures fixed with medial and lateral plating, and after immediate partial weight-bearing, up to 25 kg in all types of tibial plateau fractures fixed using a range of approaches. By using locking plates for tibial plateau fracture surgical management, surgeons can safely allow immediate postoperative weight-bearing. Immediate weight bearing did not produce additional tibial plateau depression greater than 2 mm with Schatzker Type I, II, III, or Type V fractures. This could potentially reduce the rate of postoperative complications due to immobilization, such as deep venous thrombosis and joint stiffness. Knee ROM limitations and altered gait characteristics are common complications after tibial plateau fractures. Most gait improvements occurred within the first postoperative six months. The total ROM at each lower limb joint showed positive correlations with the patients' capability to conduct normal activities of daily living. To the authors' knowledge, no randomized control study to date has investigated in patients following tibial plateau fracture surgical fixation the effect of (1) adding immediate weight bearing to tolerance in addition to a specific, tailored exercise program adapted to the type and mechanism of tibial plateau fractures; and (2) adding phones follow-ups to improve compliance and decrease the cost of care.

Interventions

Bearing weight on lower limb extremity

OTHERPragmatic Exercise protocol

Designed exercise prescriptions according to the patients' needs

Sponsors

Texas Tech University Health Sciences Center
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

The first patient from each type of Schatzker classification 1-4 tibial plateau fractures will be randomly assigned to either WBG or TG. Then each patient will be alternatively assigned to WBG or TG as a stratification method to ensure that each group has equal distribution from each type of Schatzker classification 1-4 tibial plateau fractures. The randomization file will be generated by an investigator (TH) not involved in the data collection process, with the results stored in a spreadsheet accessible only to the investigator responsible for the subjects' group assignment (MI). This investigator will not participate in any data collection or subject treatment. Due to the nature of the study, participants will not be blinded to the group assignment and treatment they will receive. However, the investigators measuring the dependent variables will be blinded to the group assignment.

Intervention model description

Randomized Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Women and men (18 to 65 years of age) admitted to Assiut University Hospital - Trauma unit with the diagnosis of traumatic tibial plateau closed fracture. 2. Open or arthroscopic internal fixation for tibial plateau fracture. 3. Schatzker classification 1-4 tibial plateau fractures. 4. An Orthopedic surgeon with at least 5 years of surgery experience. 5. Precontoured and standard locking compression plates for the tibia plateau fracture internal fixation.

Exclusion criteria

1-. Contralateral limb condition that prevents weight-bearing 3. Ipsilateral injuries such as tibial or femoral fractures, hip fractures, or pelvic ring injuries. 4\. Patients are required to wear a locking knee brace following the surgical fixation for a concomitant ligamentous knee injury. 5\. Patient treated conservatively or with external fixation. 6. Surgical fixation is delayed for more than 10 days after the injury. 7. Requirement of involved leg fixed immobilization (e.g., cast) following the surgical fixation 8. Non-ambulatory pre-tibial plateau fracture 9. Pre-injury limitation to ROM of ipsilateral knee 10. Documented psychiatric disorder (aggressive, bipolar) requiring admission in the perioperative period. 11\. Cognitive or mental condition that prevents the patient from following directions.

Design outcomes

Primary

MeasureTime frameDescription
The change in active Knee range of motionBaseline, 2 and 6 weeks, 3months after the surgeryMeasuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured
The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery6 weeks, 3 and 6 months after the surgeryArabic version of Oxford knee score.Functional knee questionnaire.The questionnaire consists of 12 questions that cover the function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
The change of radiograph measurements on X-rayBaseline and 3 months after the surgeryproximal medial tibial angle to detect varus / valgus angulation .
The change on clinical impression of reduction quality on Computed tomographyBaseline and 3 months after the surgerymeasurement of fracture gap, joint step off, tibial plateau width, tibial slope and depression will be measured to report quality of reduction and bony alignment.

Secondary

MeasureTime frameDescription
The change in Hip Stability Isometric Tests and knee extensor strength using (handheld dynamometer)6 weeks and 3 months after the surgerymeasuring the isometric muscle strength
Return to work Assessment3- and 6-month post-surgeryTime to return to work and either return to the same job or not

Other

MeasureTime frameDescription
Satisfaction with weight bearing protocol3 month after the surgeryyes or no question
Anatomical relationship of articular surfaces on X-ray6 weeks after surgeryRedflags regarding Articular congruency,the anatomical relationship of articular surfaces with or without hardware failure (Yes / NO) and visual intra-articular collapse will be measured to report bone alignment quality on x-ray
The change in average pain intensity of the lower leg using the numeric Pain Rating ScaleBaseline, 2 and 6 weeks, 3 and 6 months after surgeryScores range from 0-10 points, with higher scores indicating greater pain intensity.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026