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Fracture of Tibia Proximal PlateauNCT05502679

Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

A study testing Weight bearing as tolerated and Pragmatic Exercise protocol in people with Fracture of Tibia Proximal Plateau, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fracture of Tibia Proximal Plateau
What is being tested?
Weight bearing as tolerated and Pragmatic Exercise protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 20 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University Hospitals

    Asyut, 71515

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Weight bearing as tolerated, Pragmatic Exercise protocol
Keywords
rehabilitation, radiography, physical therapy, intra-articular knee fracture
Medical subject headings
Tibial Plateau Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight bearing as toleratedOther

    Bearing weight on lower limb extremity

  • Pragmatic Exercise protocolOther

    Designed exercise prescriptions according to the patients' needs

Study groups in NCT05502679
Study groupRoleWhat they receive
Traditional GroupActive comparator6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG)
Receives: Other: Pragmatic Exercise protocol
Weight-bearing GroupExperimentalImmediate lower limb weight bearing to tolerance rehabilitation protocol (WBG)
Receives: Other: Weight bearing as tolerated; Other: Pragmatic Exercise protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks, 3 and 6 months after the surgery

  2. The change in active Knee range of motion

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

    Measured: Baseline, 2 and 6 weeks, 3months after the surgery

  3. The change of radiograph measurements on X-ray

    proximal medial tibial angle to detect varus / valgus angulation .

    Measured: Baseline and 3 months after the surgery

  4. 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.

    Measured: Baseline and 3 months after the surgery

Secondary outcomes (2)
  1. Return to work Assessment

    Time to return to work and either return to the same job or not

    Measured: 3- and 6-month post-surgery

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

    measuring the isometric muscle strength

    Measured: 6 weeks and 3 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Jun 2024
  4. Study completion20 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502679
Sponsor's protocol ID
17200756
Status last verified
Aug 2024
First submitted
11 Aug 2022
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data will be available for the other researchers and reviewers upon request.

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.

    PubMed 30848244

Questions about this trial

What is this clinical trial studying?

A study testing Weight bearing as tolerated and Pragmatic Exercise protocol in people with Fracture of Tibia Proximal Plateau, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05502679, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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