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.
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.
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.
- Conditions
- Fracture of Tibia Proximal Plateau
- 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 group | Role | What they receive |
|---|---|---|
| Traditional Group | Active comparator | 6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG) Receives: Other: Pragmatic Exercise protocol |
| Weight-bearing Group | Experimental | Immediate 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.
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
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
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
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)
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
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.
- First posted16 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of Tibia Proximal PlateauStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Responsible party
- Principal investigator, Mariam ibrahim, Assiut University
- Investigators
- Jean-Michel Brismee, Professor, Study chair, Texas Tech Health Sciences Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05502679
- Acronym / sponsor ID
- 17200756
- Conditions
- Fracture of Tibia Proximal Plateau
- Keywords
- rehabilitation, radiography, physical therapy, intra-articular knee fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Traditional Group | Active comparator | Other: Pragmatic Exercise protocol6-week non-weight bearing of the affected lower limb rehabilitation protocol (TG) |
| Weight-bearing Group | Experimental | Other: Weight bearing as tolerated, Other: Pragmatic Exercise protocolImmediate lower limb weight bearing to tolerance rehabilitation protocol (WBG) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight bearing as toleratedBearing weight on lower limb extremity | Other | Weight-bearing Group |
| Pragmatic Exercise protocolDesigned exercise prescriptions according to the patients' needs | Other | Traditional Group, Weight-bearing Group |
Primary outcome
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
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
Time frame: Baseline, 2 and 6 weeks, 3months after the surgery
Measuring Active knee flexion and extension and at 3 month tibial rotation ROM will be measured
The change of radiograph measurements on X-ray
Time frame: Baseline and 3 months after the surgery
proximal medial tibial angle to detect varus / valgus angulation .
The change on clinical impression of reduction quality on Computed tomography
Time frame: Baseline and 3 months after the surgery
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.
2 secondary outcomes
Return to work Assessment
Time frame: 3- and 6-month post-surgery
The change in Hip Stability Isometric Tests and knee extensor strength using (handheld dynamometer)
Time frame: 6 weeks and 3 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 30848244Ahmed 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be available for the other researchers and reviewers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Brismee, Professor study chair
Texas Tech Health Sciences Center
1 site in 1 country: see every site and its status.
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.