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Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

Primary Purpose

Fracture of Tibia Proximal Plateau

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Weight bearing as tolerated
Pragmatic Exercise protocol
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Tibia Proximal Plateau focused on measuring rehabilitation, radiography, physical therapy, intra-articular knee fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Schatzker classification 5-6 tibial plateau fractures
  2. Contralateral limb condition that prevents weight bearing
  3. Ipsilateral injuries such as tibial or femoral fracture, hip fracture, or pelvic ring injury.
  4. Patients 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 7 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.
  12. Fair or poor grade on Modified Rasmussen criteria

Sites / Locations

  • Assiut University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Group

Weight-bearing Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
The change in active Knee range of motion
Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured
The change of radiograph measurements on X-ray
proximal medial tibial angle to detect varus / valgus angulation .
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.

Secondary Outcome Measures

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
The change in Hip Stability Isometric Test (HipSIT) and knee extensor strength using (handheld dynamometer)
measuring the isometric muscle strength

Full Information

First Posted
August 11, 2022
Last Updated
February 5, 2023
Sponsor
Assiut University
Collaborators
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT05502679
Brief Title
Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation
Official Title
Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Texas Tech University Health Sciences Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Tibia Proximal Plateau
Keywords
rehabilitation, radiography, physical therapy, intra-articular knee fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Group
Arm Type
Active Comparator
Arm Description
6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG)
Arm Title
Weight-bearing Group
Arm Type
Experimental
Arm Description
Immediate lower limb weight bearing to tolerance rehabilitation protocol (WBG)
Intervention Type
Other
Intervention Name(s)
Weight bearing as tolerated
Intervention Description
Bearing weight on lower limb extremity
Intervention Type
Other
Intervention Name(s)
Pragmatic Exercise protocol
Intervention Description
Designed exercise prescriptions according to the patients' needs
Primary Outcome Measure Information:
Title
The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery
Description
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.
Time Frame
6 weeks, 3 and 6 months after the surgery
Title
The change in active Knee range of motion
Description
Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured
Time Frame
Baseline, 2 and 6 weeks, 3months after the surgery
Title
The change of radiograph measurements on X-ray
Description
proximal medial tibial angle to detect varus / valgus angulation .
Time Frame
Baseline and 3 months after the surgery
Title
The change on clinical impression of reduction quality on Computed tomography
Description
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.
Time Frame
Baseline and 3 months after the surgery
Secondary Outcome Measure Information:
Title
The change of Return to work and Productivity Assessment (Arabic version).
Description
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
Time Frame
3- and 6-month post-surgery
Title
The change in Hip Stability Isometric Test (HipSIT) and knee extensor strength using (handheld dynamometer)
Description
measuring the isometric muscle strength
Time Frame
6 weeks and 3 months after the surgery
Other Pre-specified Outcome Measures:
Title
Satisfaction with weight bearing protocol
Description
yes or no question
Time Frame
3 month after the surgery
Title
The change in average pain intensity of the lower leg using the numeric Pain Rating Scale
Description
Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Time Frame
Baseline, 2 and 6 weeks, 3 and 6 months after surgery
Title
Anatomical relationship of articular surfaces on X-ray
Description
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
Time Frame
6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Reduction of tibia plateau depression is less than or equal to 2 mm (Beisemann et al. 2021) 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam A Ibrahim, Master
Phone
+201001539399
Email
mariam.a.ibrahim@med.aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel Brismee, Professor
Phone
8067433243
Email
jm.brismee@ttuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Brismee, Professor
Organizational Affiliation
Texas Tech Health Sciences Center
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Ibrahim, Msc
Phone
+201001539399
Email
ptmariamali@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30848244
Citation
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.
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Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

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