Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

NCT05502679 | Completed DMC

• 1 other identifier: 17200756
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Tibia Proximal Plateau

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Return to work Assessment

  3- and 6-month post-surgery

• The change in Hip Stability Isometric Tests and knee extensor strength using (handheld dynamometer)

  6 weeks and 3 months after the surgery

Other Outcomes (3)

• Satisfaction with weight bearing protocol

  3 month after the surgery

• The change in average pain intensity of the lower leg using the numeric Pain Rating Scale

  Baseline, 2 and 6 weeks, 3 and 6 months after surgery

• Anatomical relationship of articular surfaces on X-ray

  6 weeks after surgery

Study Arms (2)

Traditional Group

ACTIVE COMPARATOR

6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG)

Other: Pragmatic Exercise protocol

Weight-bearing Group

EXPERIMENTAL

Immediate lower limb weight bearing to tolerance rehabilitation protocol (WBG)

Other: Weight bearing as tolerated; Other: Pragmatic Exercise protocol

Interventions

Weight bearing as tolerated OTHER

Bearing weight on lower limb extremity

Weight-bearing Group

Pragmatic Exercise protocol OTHER

Designed exercise prescriptions according to the patients' needs

Traditional Group; Weight-bearing Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Open or arthroscopic internal fixation for tibial plateau fracture.
• Schatzker classification 1-4 tibial plateau fractures.
• An Orthopedic surgeon with at least 5 years of surgery experience.
• Precontoured and standard locking compression plates for the tibia plateau fracture internal fixation.

You may not qualify if:

• Contralateral limb condition that prevents weight-bearing 3. Ipsilateral injuries such as tibial or femoral fractures, hip fractures, or pelvic ring injuries.
• \. Patients are required to wear a locking knee brace following the surgical fixation for a concomitant ligamentous knee injury.
• \. 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.
• \. Cognitive or mental condition that prevents the patient from following directions.

Sponsors & Collaborators

• Assiut University: lead
• Texas Tech University Health Sciences Center: collaborator

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

Related Publications (1)

• 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.

  PMID: 30848244 BACKGROUND

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Weight-Bearing

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Jean-Michel Brismee, Professor

  Texas Tech Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 20, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 30 days
• Access Criteria: Via email

Locations

EG (1)