Tibial Plateau FracturefractureNCT06918171
Clinical Efficacy of Open Reduction and Suture Bridge Fixation for PCL Tibial Avulsion Fractures
A study testing Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation in people with Tibial Plateau Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Abstract Background: Posterior cruciate ligament (PCL) tibial avulsion fractures significantly impair knee function; however, optimal surgical fixation approaches are not agreed upon. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tibial Plateau Fracture
- What is being tested?
- Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 30 Mar 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clear diagnosis of posterior cruciate ligament (PCL) tibial avulsion fracture, verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale).
- Patients aged 18 years or older.
- Surgical management within two weeks post-injury.
- Absence of additional ligament or meniscal injuries in the affected knee, confirmed via magnetic resonance imaging (MRI).
Who cannot join
- Concurrent ligament or meniscal injuries in the affected knee, confirmed via MRI.
- Prior surgical procedures or traumatic injuries involving the same knee.
- Severe systemic diseases that could interfere with surgical outcomes (e.g., uncontrolled diabetes, severe cardiovascular disease).
- Insufficient clinical or radiographic follow-up data.
- Additional Information:
- In total, 17 patients (9 males and 8 females), with an average age of 49 ± 12 years, who satisfied all inclusion and exclusion criteria, were ultimately included for analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
The medical record system and imaging system of the Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 252000
About this study
Abstract Background: Posterior cruciate ligament (PCL) tibial avulsion fractures significantly impair knee function; however, optimal surgical fixation approaches are not agreed upon. The investigators performed this study to compare the clinical outcomes of PCL tibial avulsion fractures treated with open reduction and anchor suture bridge fixation.
Methods: A total of 17 patients underwent open reduction and anchor suture bridge fixation following injury. The investigators recorded operation time, intraoperative and postoperative complications, and used imaging to assess fracture reduction and healing. Visual Analog Scale (VAS), Lysholm Knee Scoring Scale, International Knee Documentation Committee (IKDC) score, and knee range of motion (ROM) were evaluated preoperatively, 3 months postoperatively, and at final follow-up.
Read the detailed description
Patient Selection This study was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University. The ethics number was: JD-HG-2025-035. From January 2019 to December 2023, patients diagnosed with PCL tibial avulsion fractures and treated with open reduction combined with anchor fixation at our center were evaluated for inclusion. Inclusion criteria were: (1) a clear diagnosis of PCL tibial avulsion fracture verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale)[16]; (2) patients aged 18 years or older; (3) surgical management within two weeks post-injury; and (4) absence of additional ligament or meniscal injuries in the affected knee. Exclusion criteria were: (1) concurrent ligament or meniscal injuries confirmed via magnetic resonance imaging (MRI); (2) prior surgical procedures or traumatic injuries involving the same knee; (3) severe systemic diseases that could interfere with surgical outcomes; and (4) insufficient clinical or radiographic follow-up data. In total, 17 patients (9 males and 8 females), with an average age of 49 ± 12 years, who satisfied all inclusion and exclusion criteria, were ultimately included for analysis.
Surgical Techniques All surgeries were carried out by the same experienced orthopedic surgeon to ensure procedural consistency. Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing the suture construct effectively. Intraoperative fluoroscopy was utilized to verify proper fracture reduction and secure fixation. Upon confirmation, the surgical site was irrigated, hemostasis was achieved, and the incision was closed in layers.
Postoperative Management Postoperatively, all patients were immobilized with a hinged knee brace locked in full extension for the initial 2 weeks, and partial weight-bearing with crutches was permitted as tolerated. Passive knee range-of-motion exercises (0°-60°) were initiated under supervised rehabilitation 2 weeks after surgery. At 4-6 weeks postoperatively, progressive weight-bearing was encouraged according to fracture healing confirmed by radiographic assessment, and knee flexion was gradually increased (0°-90°). After 8 weeks, patients transitioned to full weight-bearing, and active muscle strengthening and proprioception training programs were initiated.
Clinical Assessments Clinical outcomes were comprehensively assessed at three distinct time points: prior to surgery, at 3 months postoperatively, and at the final follow-up visit. The key evaluation parameters included pain intensity, knee joint function, range of motion (ROM), fracture healing, and postoperative complications. Pain severity was quantified using the Visual Analog Scale (VAS; 0-10 points), where 0 indicates no pain and 10 represents the worst possible pain. Functional outcomes were evaluated with two well-established scoring systems: the Lysholm Knee Scoring Scale (ranging from 0 to 100, where higher scores indicate better knee function) and the International Knee Documentation Committee (IKDC) subjective knee assessment (also ranging from 0 to 100, with higher values reflecting superior functional status). Knee ROM, encompassing both maximal flexion and extension, was measured using a standard goniometer. Fracture union was assessed via routine anteroposterior and lateral radiographs, with successful healing defined as the presence of continuous cortical alignment and trabecular bridging at the fracture site, without detectable fracture lines. In addition, any postoperative complications, including infection, neurovascular injuries, hardware-related issues, implant discomfort, or the necessity for reoperation, were meticulously documented during each follow-up assessment.
Statistical Analysis Statistical analyses were conducted using SPSS software (version 26.0). Continuous variables were expressed as mean ± standard deviation (SD) or as median with interquartile range (IQR), depending on the data distribution. The Shapiro-Wilk test was applied to examine the normality of continuous variables. Comparisons of clinical outcomes, including VAS pain scores, Lysholm knee scores, IKDC scores, and knee range of motion (ROM), across preoperative and postoperative time points were evaluated using the Friedman test for repeated measures, with Wilcoxon signed-rank tests employed for post hoc pairwise comparisons. Categorical variables, such as complication rates, were summarized as frequencies and percentages. A P-value < 0.05 was considered indicative of statistical significance in all analyses.
- Conditions
- Tibial Plateau Fracture
- Being tested
- Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation
- Keywords
- fracture fixation, Retrospective study
- 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.
Clinical Efficacy of Open Reduction and Anchor Suture Bridge FixationProcedure or surgery
Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing
| Study group | Role | What they receive |
|---|---|---|
| Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation | Experimental | Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securin Receives: Procedure: Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Score
The Visual Analog Scale (VAS) Score is used to assess the intensity of pain experienced by patients. The VAS is a continuous scale comprising a 100-mm line, where the minimum value is 0 (representing no pain) and the maximum value is 10 (representing the worst imaginable pain). A higher score indicates a worse outcome, reflecting greater pain intensity. The mean VAS score across all participants will be reported to evaluate the average pain level at 6 months post-surgery.
Measured: 6 months after surgery
Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is used to evaluate knee function and symptoms. The scale ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function and fewer symptoms. The scale assesses factors such as pain, instability, locking, swelling, and the ability to perform activities like climbing stairs or squatting. The mean Lysholm score across all participants will be reported to evaluate the average knee function at 6 months post-surgery.
Measured: 6 months after surgery
International Knee Documentation Committee Score
The International Knee Documentation Committee (IKDC) Score is used to evaluate knee function, symptoms, and the ability to engage in sports activities following surgery. The IKDC Score ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function, fewer symptoms, and better overall knee health. The score assesses aspects such as pain, swelling, knee stability, and the ability to perform daily activities and sports. The mean IKDC score across all participants will be reported to evaluate the average knee function and sports activity level at 6 months post-surgery.
Measured: 6 months after surgery
Range of Motion
The Range of Motion (ROM) of the knee is measured to assess the degree of knee flexion and extension following surgery. ROM is evaluated using a goniometer, with measurements recorded in degrees. The minimum value for knee flexion is 0 degrees (indicating no flexion, i.e., a fully extended knee), and the maximum value can reach up to approximately 135 degrees in a healthy knee (indicating full flexion). For extension, the minimum value is 0 degrees (full extension), while negative values (e.g., -5 degrees) may indicate an extension deficit. A greater ROM, particularly in flexion, indicates a better outcome, reflecting improved knee mobility and function. The mean flexion and extension angles across all participants will be reported to evaluate the average knee mobility at 6 months post-surgery.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Mar 2025
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FractureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918171
- Sponsor's protocol ID
- JD-HG-2025-035
- Acronym
- fracture
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Open Reduction and Suture Bridge Fixation for PCL Tibial Avulsion Fractures
- ClinicalTrials.gov ID
- NCT06918171
- Acronym / sponsor ID
- fracture / JD-HG-2025-035
- Conditions
- Tibial Plateau Fracture
- Keywords
- fracture fixation, Retrospective study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 9 Apr 2025 (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.
Abstract Background: Posterior cruciate ligament (PCL) tibial avulsion fractures significantly impair knee function; however, optimal surgical fixation approaches are not agreed upon. The investigators performed this study to compare the clinical outcomes of PCL tibial avulsion fractures treated with open reduction and anchor suture bridge fixation.
Methods: A total of 17 patients underwent open reduction and anchor suture bridge fixation following injury. The investigators recorded operation time, intraoperative and postoperative complications, and used imaging to assess fracture reduction and healing. Visual Analog Scale (VAS), Lysholm Knee Scoring Scale, International Knee Documentation Committee (IKDC) score, and knee range of motion (ROM) were evaluated preoperatively, 3 months postoperatively, and at final follow-up.
Detailed description
Patient Selection This study was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University. The ethics number was: JD-HG-2025-035. From January 2019 to December 2023, patients diagnosed with PCL tibial avulsion fractures and treated with open reduction combined with anchor fixation at our center were evaluated for inclusion. Inclusion criteria were: (1) a clear diagnosis of PCL tibial avulsion fracture verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale)[16]; (2) patients aged 18 years or older; (3) surgical management within two weeks post-injury; and (4) absence of additional ligament or meniscal injuries in the affected knee. Exclusion criteria were: (1) concurrent ligament or meniscal injuries confirmed via magnetic resonance imaging (MRI); (2) prior surgical procedures or traumatic injuries involving the same knee; (3) severe systemic diseases that could interfere with surgical outcomes; and (4) insufficient clinical or radiographic follow-up data. In total, 17 patients (9 males and 8 females), with an average age of 49 ± 12 years, who satisfied all inclusion and exclusion criteria, were ultimately included for analysis.
Surgical Techniques All surgeries were carried out by the same experienced orthopedic surgeon to ensure procedural consistency. Under general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing the suture construct effectively. Intraoperative fluoroscopy was utilized to verify proper fracture reduction and secure fixation. Upon confirmation, the surgical site was irrigated, hemostasis was achieved, and the incision was closed in layers.
Postoperative Management Postoperatively, all patients were immobilized with a hinged knee brace locked in full extension for the initial 2 weeks, and partial weight-bearing with crutches was permitted as tolerated. Passive knee range-of-motion exercises (0°-60°) were initiated under supervised rehabilitation 2 weeks after surgery. At 4-6 weeks postoperatively, progressive weight-bearing was encouraged according to fracture healing confirmed by radiographic assessment, and knee flexion was gradually increased (0°-90°). After 8 weeks, patients transitioned to full weight-bearing, and active muscle strengthening and proprioception training programs were initiated.
Clinical Assessments Clinical outcomes were comprehensively assessed at three distinct time points: prior to surgery, at 3 months postoperatively, and at the final follow-up visit. The key evaluation parameters included pain intensity, knee joint function, range of motion (ROM), fracture healing, and postoperative complications. Pain severity was quantified using the Visual Analog Scale (VAS; 0-10 points), where 0 indicates no pain and 10 represents the worst possible pain. Functional outcomes were evaluated with two well-established scoring systems: the Lysholm Knee Scoring Scale (ranging from 0 to 100, where higher scores indicate better knee function) and the International Knee Documentation Committee (IKDC) subjective knee assessment (also ranging from 0 to 100, with higher values reflecting superior functional status). Knee ROM, encompassing both maximal flexion and extension, was measured using a standard goniometer. Fracture union was assessed via routine anteroposterior and lateral radiographs, with successful healing defined as the presence of continuous cortical alignment and trabecular bridging at the fracture site, without detectable fracture lines. In addition, any postoperative complications, including infection, neurovascular injuries, hardware-related issues, implant discomfort, or the necessity for reoperation, were meticulously documented during each follow-up assessment.
Statistical Analysis Statistical analyses were conducted using SPSS software (version 26.0). Continuous variables were expressed as mean ± standard deviation (SD) or as median with interquartile range (IQR), depending on the data distribution. The Shapiro-Wilk test was applied to examine the normality of continuous variables. Comparisons of clinical outcomes, including VAS pain scores, Lysholm knee scores, IKDC scores, and knee range of motion (ROM), across preoperative and postoperative time points were evaluated using the Friedman test for repeated measures, with Wilcoxon signed-rank tests employed for post hoc pairwise comparisons. Categorical variables, such as complication rates, were summarized as frequencies and percentages. A P-value < 0.05 was considered indicative of statistical significance in all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation | Experimental | Procedure: Clinical Efficacy of Open Reduction and Anchor Suture Bridge FixationUnder general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clear diagnosis of posterior cruciate ligament (PCL) tibial avulsion fracture, verified through preoperative radiographs and computed tomography (CT), with classification as type II or III based on the Griffith system (a modified Meyers and McKeever scale).
- Patients aged 18 years or older.
- Surgical management within two weeks post-injury.
- Absence of additional ligament or meniscal injuries in the affected knee, confirmed via magnetic resonance imaging (MRI).
Key exclusion criteria (6 listed)
- Concurrent ligament or meniscal injuries in the affected knee, confirmed via MRI.
- Prior surgical procedures or traumatic injuries involving the same knee.
- Severe systemic diseases that could interfere with surgical outcomes (e.g., uncontrolled diabetes, severe cardiovascular disease).
- Insufficient clinical or radiographic follow-up data.
- In total, 17 patients (9 males and 8 females), with an average age of 49 ± 12 years, who satisfied all inclusion and exclusion criteria, were ultimately included for analysis.
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 |
|---|---|---|
| Clinical Efficacy of Open Reduction and Anchor Suture Bridge FixationUnder general anesthesia, patients were positioned prone, and a midline posterior incision was made at the level of the popliteal fossa. After incising the fascia, careful dissection was undertaken to expose the posterior joint capsule and fracture fragment, with particular attention to safeguarding the neurovascular structures. Once the fracture site was fully exposed, hematoma and any interposing soft tissue were meticulously cleared to prepare for reduction. The avulsed bone fragment, located at the PCL insertion site, was identified and prepared for fixation. A suture anchor (Johnson \& Johnson, USA) was carefully implanted into the prepared osseous bed. The suture threads were passed anteriorly around the PCL and configured in a figure-of-eight pattern to achieve precise anatomical reduction of the fracture fragment. To enhance fixation stability, two extracortical anchors (Johnson \& Johnson, USA) were additionally positioned approximately 2 cm distal to the fracture site, securing | Procedure or surgery | Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation |
Primary outcome
Visual Analog Scale Score
Time frame: 6 months after surgery
The Visual Analog Scale (VAS) Score is used to assess the intensity of pain experienced by patients. The VAS is a continuous scale comprising a 100-mm line, where the minimum value is 0 (representing no pain) and the maximum value is 10 (representing the worst imaginable pain). A higher score indicates a worse outcome, reflecting greater pain intensity. The mean VAS score across all participants will be reported to evaluate the average pain level at 6 months post-surgery.
Lysholm Knee Scoring Scale
Time frame: 6 months after surgery
The Lysholm Knee Scoring Scale is used to evaluate knee function and symptoms. The scale ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function and fewer symptoms. The scale assesses factors such as pain, instability, locking, swelling, and the ability to perform activities like climbing stairs or squatting. The mean Lysholm score across all participants will be reported to evaluate the average knee function at 6 months post-surgery.
International Knee Documentation Committee Score
Time frame: 6 months after surgery
The International Knee Documentation Committee (IKDC) Score is used to evaluate knee function, symptoms, and the ability to engage in sports activities following surgery. The IKDC Score ranges from a minimum value of 0 to a maximum value of 100. A higher score indicates a better outcome, reflecting improved knee function, fewer symptoms, and better overall knee health. The score assesses aspects such as pain, swelling, knee stability, and the ability to perform daily activities and sports. The mean IKDC score across all participants will be reported to evaluate the average knee function and sports activity level at 6 months post-surgery.
Range of Motion
Time frame: 6 months after surgery
The Range of Motion (ROM) of the knee is measured to assess the degree of knee flexion and extension following surgery. ROM is evaluated using a goniometer, with measurements recorded in degrees. The minimum value for knee flexion is 0 degrees (indicating no flexion, i.e., a fully extended knee), and the maximum value can reach up to approximately 135 degrees in a healthy knee (indicating full flexion). For extension, the minimum value is 0 degrees (full extension), while negative values (e.g., -5 degrees) may indicate an extension deficit. A greater ROM, particularly in flexion, indicates a better outcome, reflecting improved knee mobility and function. The mean flexion and extension angles across all participants will be reported to evaluate the average knee mobility at 6 months post-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 9 Apr 2025.
- Individual participant dataSharing planned: Yes
Related trials for Tibial Plateau Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Recruiting
Comparison of Functional Outcome Between Locking Plate Technique Versus Hybrid Ilizarov Technique in Patients With Schatzker Type V and VI Tibial Plateau Fractures
Tibial Plateau Fracture
Recruiting
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Fractures, Bone
Enrolling by invitation
Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
Tibial Shaft Fracture, Tibial Plateau Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Efficacy of Open Reduction and Anchor Suture Bridge Fixation in people with Tibial Plateau Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 4 inclusion and 6 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 9 Apr 2025. 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 China. 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?
Visual Analog Scale Score (time frame: 6 months after 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?
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 9 Apr 2025.