## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 17200756
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2022-08-16
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-11
**Study First Submit QC Date:** 2022-08-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Texas Tech University Health Sciences Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Mariam ibrahim

**Investigator Title:** Principle investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Fracture of Tibia Proximal Plateau

**Keywords:**

- rehabilitation

- radiography

- physical therapy

- intra-articular knee fracture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized Clinical Trial

##### Masking Info

**Masking:** DOUBLE

**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.

**Who Masked:**

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Pragmatic Exercise protocol

**Label:** Traditional Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Other: Weight bearing as tolerated

- Other: Pragmatic Exercise protocol

**Label:** Weight-bearing Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Weight-bearing Group

**Description:** Bearing weight on lower limb extremity

**Name:** Weight bearing as tolerated

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Traditional Group

- Weight-bearing Group

**Description:** Designed exercise prescriptions according to the patients' needs

**Name:** Pragmatic Exercise protocol

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** yes or no question

**Measure:** Satisfaction with weight bearing protocol

**Time Frame:** 3 month after the surgery

**Description:** Scores range from 0-10 points, with higher scores indicating greater pain intensity.

**Measure:** The change in average pain intensity of the lower leg using the numeric Pain Rating Scale

**Time Frame:** Baseline, 2 and 6 weeks, 3 and 6 months after surgery

**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

**Measure:** Anatomical relationship of articular surfaces on X-ray

**Time Frame:** 6 weeks after surgery

#### Primary Outcomes

**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.

**Measure:** The change in Oxford knee score (OKS) from 6 weeks to 3 months and 6 months after surgery

**Time Frame:** 6 weeks, 3 and 6 months after the surgery

**Description:** Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured

**Measure:** The change in active Knee range of motion

**Time Frame:** Baseline, 2 and 6 weeks, 3months after the surgery

**Description:** proximal medial tibial angle to detect varus / valgus angulation .

**Measure:** The change of radiograph measurements on X-ray

**Time Frame:** Baseline and 3 months after the surgery

**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.

**Measure:** The change on clinical impression of reduction quality on Computed tomography

**Time Frame:** Baseline and 3 months after the surgery

#### Secondary Outcomes

**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

**Measure:** The change of Return to work and Productivity Assessment (Arabic version).

**Time Frame:** 3- and 6-month post-surgery

**Description:** measuring the isometric muscle strength

**Measure:** The change in Hip Stability Isometric Test (HipSIT) and knee extensor strength using (handheld dynamometer)

**Time Frame:** 6 weeks and 3 months after the surgery

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mariam.a.ibrahim@med.aun.edu.eg

**Name:** Mariam A Ibrahim, Master

**Phone:** +201001539399

**Role:** CONTACT

**Contact 2:**

**Email:** jm.brismee@ttuhsc.edu

**Name:** Jean-Michel Brismee, Professor

**Phone:** 8067433243

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Assiut

**Contacts:**

***Contact 1:***

- **Email:** ptmariamali@hotmail.com

- **Name:** Mariam Ibrahim, Msc

- **Phone:** +201001539399

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Assiut University Hospitals

**Status:** RECRUITING

**Zip:** 71515

#### Overall Officials

**Official 1:**

**Affiliation:** Texas Tech Health Sciences Center

**Name:** Jean-Michel Brismee, Professor

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Access Criteria:** Via email

**Description:** Deidentified data will be available for the other researchers and reviewers upon request.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** 30 days

### References Module

#### References

**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.

**PMID:** 30848244

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000092443

- Term: Knee Fractures

- ID: D000007718

- Term: Knee Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M16737

- Name: Tibial Fractures

- Relevance: HIGH

- As Found: Fracture of Tibia

- ID: M2925

- Name: Tibial Plateau Fractures

- Relevance: HIGH

- As Found: Tibial Plateau Fractures

- ID: M2923

- Name: Knee Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10738

- Name: Knee Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000092463

- Term: Tibial Plateau Fractures

- ID: D000013978

- Term: Tibial Fractures

### Misc Info Module

- Version Holder: 2024-05-24
