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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture of Tibia Proximal Plateau
• Intervention / Treatment: Other: Pragmatic Exercise protocol; Other: Weight bearing as tolerated

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam A Ibrahim, Master; Phone Number: +201001539399; Email: mariam.a.ibrahim@med.aun.edu.eg
• Study Contact Backup: Name: Jean-Michel Brismee, Professor; Phone Number: 8067433243; Email: jm.brismee@ttuhsc.edu

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut university hospitals
    • Contact: Mariam Ibrahim, Msc; Phone Number: +201001539399; Email: ptmariamali@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Reduction of tibia plateau depression is less than or equal to 2 mm (Beisemann et al. 2021)
4. Schatzker classification 1-4 tibial plateau fractures.
5. An Orthopedic surgeon with at least 5 years of surgery experience.
6. Precontoured and standard locking compression plates for the tibia plateau fracture internal fixation.
7. An excellent or good grade on Modified Rasmussen criteria.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Group; 6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG)	Other: Pragmatic Exercise protocol; Designed exercise prescriptions according to the patients' needs
Experimental: Weight-bearing Group; Immediate lower limb weight bearing to tolerance rehabilitation protocol (WBG)	Other: Pragmatic Exercise protocol; Designed exercise prescriptions according to the patients' needs; Other: Weight bearing as tolerated; Bearing weight on lower limb extremity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery	Arabic 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.	6 weeks, 3 and 6 months after the surgery
The change in active Knee range of motion	Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured	Baseline, 2 and 6 weeks, 3months after the surgery
The change of radiograph measurements on X-ray	proximal medial tibial angle to detect varus / valgus angulation .	Baseline and 3 months after the surgery
The change on clinical impression of reduction quality on Computed tomography	measurement of fracture gap, joint step off, tibial plateau width, tibial slope and depression will be measured to report quality of reduction and bony alignment.	Baseline and 3 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Return to work and Productivity Assessment (Arabic version).	work and Productivity Assessment outcomes are expressed as impairment percentages, with higher numbers indicating Greater impairment and less productivity, i.e., worse outcomes. minimum score is 0 and maximum is 100	3- and 6-month post-surgery
The change in Hip Stability Isometric Test (HipSIT) and knee extensor strength using (handheld dynamometer)	measuring the isometric muscle strength	6 weeks and 3 months after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with weight bearing protocol	yes or no question	3 month after the surgery
The change in average pain intensity of the lower leg using the numeric Pain Rating Scale	Scores range from 0-10 points, with higher scores indicating greater pain intensity.	Baseline, 2 and 6 weeks, 3 and 6 months after surgery
Anatomical relationship of articular surfaces on X-ray	Redflags 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	6 weeks after surgery

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: Texas Tech University Health Sciences Center
• Investigators: Study Chair: Jean-Michel Brismee, Professor, Texas Tech Health Sciences Center

Publications and helpful links

General Publications

• Ahmed KM, Said HG, Ramadan EKA, Abd El-Radi M, El-Assal MA. Arabic translation and validation of three knee scores, Lysholm Knee Score (LKS), Oxford Knee Score (OKS), and International Knee Documentation Committee Subjective Knee Form (IKDC). SICOT J. 2019;5:6. doi: 10.1051/sicotj/2018054. Epub 2019 Mar 8. Erratum In: SICOT J. 2019;5:27.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; physical therapy; radiography; intra-articular knee fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Knee Fractures; Fractures, Bone; Tibial Fractures; Tibial Plateau Fractures
• Other Study ID Numbers: 17200756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be available for the other researchers and reviewers upon request.
• IPD Sharing Time Frame: 30 days
• IPD Sharing Access Criteria: Via email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No