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Enrolling by invitation NCT07251699

EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES

No phase Interventional Tibial Plateau Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist.
Who it may be relevant to
Registry conditions: Tibial Plateau Fractures. Basic parameters: 25 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

COMBINED EFFECT OF EARLY WEIGHT BEARING AND ACTIVE KNEE EXERCISES IN TREATMENT OF TIBIAL PLATEAU FRACTURES WITH INTERNAL FIXATION

Overview

This study will answer the following research questions: Are there any significant differences between combination of early active knee ROM exercises and weight bearing versus early passive ROM with delayed weight bearing on pain intensity, ROM knee flexion and extension, function, and radiological healing in treatment of patients with TPFs fixed with plates and screws?

Detailed description

This study will be conducted to compare the effects of combining early active knee ROM exercises and weight bearing versus early passive ROM and delayed weight bearing on pain intensity, ROM knee flexion and extension, function, and radiological healing in treatment of patients with TPFs fixed with plates and screws.

Tibial plateau fractures are associated with unfavorable outcomes due to a variety of factors, including soft tissue envelopes and cartilage damage, comorbidities such as compartment syndrome, postoperative infection, stiffness or malfunction of the knee, and even post-traumatic osteoarthritis (Narang et al., 2021). Consequently, they not only present surgical challenges but also have serious negative effects on function and quality of life (Arnold et al., 2017; Bhamra and Naqvi, 2021).

Physical therapy including active exercises is well supported in literature but in the late phases of rehabilitation. The concept of introducing early active exercises to patients undergoing rehabilitation following TPFs repaired with implants isn't well-supported in the literature. There aren't any comprehensive studies that specifically examine the application of early active exercises for TPFs repaired with plates and screws (Phansopkar et al., 2022).

There are few studies in form of case reports that applied early active exercises for patients with TPFs. It was found that appropriate surgical intervention followed with planned exercise protocol focussing on long term benefits can greatly help patients with TPFs to achieve early pain free mobility in lower limbs (Narang et al., 2021; Arya and Harjpal, 2023; Bhure et al., 2022).

this study will assess the long term effects of the treatment program for patients with TPFs fixed with plates and screws. So this study will be conducted, using valid and reliable methods and instrumentations, to determine if there are any effects of combined effect of early active 6 exercises and early weight bearing in treatment of patients with TPFs fixed with plates and screws which will add a new step in the pyramid of evidence for the best treatment methods for patients with TPFs fixed with plates and screws.

Interventions

  • Other Early active exercises will be applied from the first day by the participation of the patient with the assistance of the physiotherapist
    The difference between each group is in the first four weeks and the type of program group one started with active exercise from the first day 38 group 2 active exercises started from week five at the first four weeks program is done by passive ROM modalities and by the physiotherapist. Early weight bearing is early in group 1 from the first week and late in group 2 after four weeks

Primary outcome measures

  • Numerical Pain Rating Scale [Time frame: 5 min]
  • Modified Rasmussen Radiologic Score [Time frame: 5 min]
Secondary outcome measures (2)
  • Universal Goniometer [Time frame: 5 min]
  • Arabic version of the Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 5 min]

Eligibility criteria

Inclusion criteria

  • Inclusion Criteria Participants will be included in the study if they had TPF type II Schatzker fixed with plate and screws. Their aged range from 18-50 years old while their BMI range from 18.5 to 29.9 kg/m2 (Mohamed et 25 al., 2019; Hoseini et al., 2022; Phansopkar et al., 2022). They are referred from an orthopedic surgeon immediately after the operation.

Exclusion Criteria Participants will be excluded from this study if they didn't fulfil the inclusion criteria or if they had one of the following. Other types of TPFs or methods of fixation, previous hip or lower extremity injury or surgery e.g. arthroplasty, systemic diseases e.g. diabetes, rheumatoid arthritis, pathological conditions of the lower extremities e.g. tumours, infections, leg deformity, cardiovascular disease such as hypertension, and neurological diseases.

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • faculty of physical therapy cairo university, Giza, — Giza

Identifiers

NCT: NCT07251699 · tibial plateau early rehab

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗