Patella FractureNCT07248982
High-Strength Suture vs. Traditional Tension Band for Patellar Fractures
An observational study of Patella Fracture, run by Fuzhou University Affiliated Provincial Hospital at 1 site in China.
Trial summary
This prospective cohort study aims to evaluate the clinical efficacy of high-strength suture modified tension band fixation in treating patellar fractures and compare it with traditional screw-cable tension band fixation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Patella Fracture
- What is being tested?
- High-Strength Suture Modified Tension Band Fixation and Screw-Cable Tension Band Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with patellar fractures seeking surgical treatment at Fuzhou University Affiliated Provincial Hospital, meeting inclusion criteria, and grouped based on surgical technique received.
Who may be able to join
- 1.Age 18-55 years. 2.Radiographically confirmed patellar fracture (AO/OTA 34-C1 or 34-C2). 3.First-time patellar fracture surgery. 4.Time from injury to surgery ≤ 2 weeks. 5.Able to comply with follow-up and provide written informed consent. 6.Normal pre-injury knee function. 7.Able to tolerate surgery and agree to surgical treatment. 8.Intact cognitive function.
Who cannot join
- 1.Age <18 or >55 years. 2.Pathological fractures. 3.Prior patellar surgery or severe underlying patellofemoral disease. 4.Time from injury to surgery >2 weeks. 5.Concurrent active infection or severe medical conditions. 6.Severe neuropsychiatric disorders affecting follow-up compliance. 7.Postmenopausal women. 8.Inability to tolerate surgery or refusal of surgery. 9.Comorbid patellar dysplasia, rheumatoid arthritis, or other patellofemoral diseases.
- 10.Comorbid systemic or local infection at surgical site. 11.Comorbid severe lower limb or systemic injuries. 12.Pre-injury cognitive impairment, mental disorder, or independent walking disability.
- 13.Other conditions unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001
Wei Xu, Dr, +8613959116868, drxuwei@sina.com
About this study
Official title: Prospective Cohort Study of High-Strength Suture Modified Tension Band Technique for the Treatment of Patellar Fractures
This prospective cohort study aims to evaluate the clinical efficacy of high-strength suture modified tension band fixation in treating patellar fractures and compare it with traditional screw-cable tension band fixation. Adult patients (18-55 years) with AO/OTA 34-C1 or 34-C2 patellar fractures will be enrolled and followed for 12 months. Primary outcomes include Lysholm knee function score, knee range of motion (ROM), and visual analog scale (VAS) pain score at 12 months post-surgery. Secondary outcomes include fracture healing time, radiographic alignment quality, complication rates, reoperation rates, implant removal rates, SF-36 health survey scores, and patient satisfaction. No additional biological samples will be collected; data will focus on clinical, radiographic, and follow-up information.
Read the detailed description
Patellar fractures account for approximately 1% of all fractures and are common in knee injuries. Traditional tension band fixation is widely used but associated with issues such as hardware migration, soft tissue irritation, and postoperative pain, impacting rehabilitation and quality of life. High-strength sutures offer improved biomechanical properties, flexibility, and reduced soft tissue damage. This study observes the clinical efficacy of high-strength suture modified tension band fixation compared to traditional methods through a prospective cohort design.
Patients admitted to Fuzhou University Affiliated Provincial Hospital from February 2024 to February 2026 with patellar fractures undergoing surgery will be divided into two groups based on surgical method: Suture Fixation (SF) group and Screw-Cable Tension Band (SCTB) group. Follow-up will occur for 12 months, assessing outcomes such as postoperative VAS pain scores, Lysholm knee scores, ROM, SF-36 health surveys, surgical time, intraoperative blood loss, hospital stay, and complications (e.g., infection, fixation failure, nonunion).
General data collected includes demographics (age, gender, height, weight, BMI), comorbidities (e.g., diabetes, hypertension, smoking), ASA classification, fracture details (side, type, displacement, mechanism, time from injury), and perioperative complications. Imaging assessments include fracture reduction quality (good, satisfactory, poor) via X-ray, healing time (weeks until fracture line blurs/disappears), and patellar height via Insall-Salvati index. Muscle strength (quadriceps via MMT, 0-5 grades) and patient satisfaction (1-5 scale) will also be evaluated.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded, reported to the ethics committee, and managed promptly. Statistical analysis will use IBM SPSS Statistics 27.0, with t-tests, Mann-Whitney U tests, chi-square/Fisher's exact tests, Kaplan-Meier curves, and regressions as appropriate. Intention-to-treat (ITT) analysis will be primary, with multiple imputation for missing data.
The study is feasible given the hospital's patient volume and the principal investigator's experience. Ethical principles follow the Helsinki Declaration, with informed consent and privacy protection. Results will be published in academic journals and presented at conferences.
- Conditions
- Patella Fracture
- Being tested
- High-Strength Suture Modified Tension Band Fixation, Screw-Cable Tension Band Fixation
- Keywords
- Patellar Fracture, Tension Band Fixation, High-Strength Suture, Knee Function, Lysholm Score, VAS Pain Score, Prospective Cohort
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Strength Suture Modified Tension Band FixationProcedure or surgery
Also called Suture Fixation (SF)
Use of high-strength sutures for modified tension band fixation in patellar fracture surgery.
Screw-Cable Tension Band FixationProcedure or surgery
Use of screws and cables for traditional modified tension band fixation in patellar fracture surgery.
| Study group | Role | What they receive |
|---|---|---|
| Suture Fixation (SF) Group | Patients receiving high-strength suture modified tension band fixation for patellar fracture. Receives: Procedure: High-Strength Suture Modified Tension Band Fixation | |
| Screw-Cable Tension Band (SCTB) Group | Patients receiving traditional screw-cable tension band fixation for patellar fracture. Receives: Procedure: Screw-Cable Tension Band Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Knee Score at 12 Months Postoperatively
Lysholm knee scoring scale (0-100 points; 95-100 = excellent, 84-94 = good, 65-83 = fair, <65 = poor; higher scores indicate better knee function). Assessed at baseline (pre-injury recalled), 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
Measured: 12 months postoperatively
Knee Range of Motion at 12 Months Postoperatively
Active knee flexion and extension range of motion measured in degrees with a goniometer (higher values indicate better function). Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
Measured: 12 months postoperatively
Visual Analog Scale (VAS) Pain Score at 12 Months Postoperatively
Visual Analog Scale for pain (0-10 points; 0 = no pain, 10 = worst imaginable pain; higher scores indicate more severe pain). Assessed preoperatively and at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
Measured: 12 months postoperatively
Secondary outcomes (11)
Fracture Healing Time
Time in weeks from surgery until radiographic evidence of fracture line blurring or disappearance on X-ray/CT.
Measured: Assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively or until healing confirmed
Radiographic Alignment Quality
Postoperative fracture reduction quality graded as good, satisfactory, or poor based on X-ray.
Measured: Immediately postoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively
Complication Rate
Incidence of any postoperative complications (e.g., infection, fixation failure, nonunion, knee stiffness, deep vein thrombosis).
Measured: From surgery to 12 months postoperatively
Reoperation Rate
Percentage of patients requiring any additional surgery related to the index fracture.
Measured: From surgery to 12 months postoperatively
Implant Removal Rate
Percentage of patients requiring removal of surgical implants.
Measured: From surgery to 12 months postoperatively
SF-36 (36-Item Short Form Health Survey) Score
36-Item Short Form Health Survey (SF-36) questionnaire assessing health-related quality of life. The SF-36 includes eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health); scores for each domain range from 0-100, with higher scores indicating better health status. The Physical Component Summary (PCS) and Mental Component Summary (MCS) will also be calculated and reported. Assessed at 12 months postoperatively.
Measured: 12 months postoperatively
Surgical Time
Duration of the surgical procedure recorded in minutes from skin incision to closure.
Measured: Day of surgery
Intraoperative Blood Loss
Estimated volume of blood loss during surgery recorded in milliliters.
Measured: Day of surgery
Hospital Stay Duration
Number of days from the date of surgery to the date of hospital discharge.
Measured: From day of surgery to discharge
Quadriceps Muscle Strength (Manual Muscle Testing)
Quadriceps strength graded 0-5 using Manual Muscle Testing (MMT; 0 = no contraction, 5 = normal strength), compared with the contralateral side.
Measured: Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively
Patellar Height (Insall-Salvati Index)
Ratio of patellar tendon length to patellar length measured on lateral knee radiographs (normal range 0.8-1.2).
Measured: Assessed at 1 month, 3 months, 6 months, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Feb 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patella 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou University Affiliated Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anning Liu, Fuzhou University Affiliated Provincial Hospital
- Investigators
- Wei Xu, Dr, Principal investigator, Fuzhou University Affiliated Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248982
- Sponsor's protocol ID
- K2025-10-005
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only aggregated study results and summary statistics will be made available through publications and conference presentations.
Publications
Adjal J, Haugaard A, Vesterby L, Ibrahim HM, Sert K, Thomsen MG, Tengberg PT, Ban I, Ohrt-Nissen S. Suture tension band fixation vs. metallic tension band wiring for patella fractures - A biomechanical study on 19 human cadaveric patellae. Injury. 2022 Aug;53(8):2749-2753. doi: 10.1016/j.injury.2022.05.015. Epub 2022 May 26.
PubMed 35701245Hughes SC, Stott PM, Hearnden AJ, Ripley LG. A new and effective tension-band braided polyester suture technique for transverse patellar fracture fixation. Injury. 2007 Feb;38(2):212-22. doi: 10.1016/j.injury.2006.07.013. Epub 2006 Nov 13.
PubMed 17098238Carpenter JE, Kasman RA, Patel N, Lee ML, Goldstein SA. Biomechanical evaluation of current patella fracture fixation techniques. J Orthop Trauma. 1997 Jul;11(5):351-6. doi: 10.1097/00005131-199707000-00009.
PubMed 9294799LeBrun CT, Langford JR, Sagi HC. Functional outcomes after operatively treated patella fractures. J Orthop Trauma. 2012 Jul;26(7):422-6. doi: 10.1097/BOT.0b013e318228c1a1.
PubMed 22183197Sayum Filho J, Lenza M, Tamaoki MJ, Matsunaga FT, Belloti JC. Interventions for treating fractures of the patella in adults. Cochrane Database Syst Rev. 2021 Feb 24;2(2):CD009651. doi: 10.1002/14651858.CD009651.pub3.
PubMed 33625743Huang L, Li X, Ye L, Li S. Closed Reduction and High-Strength Sutures for Transverse Patella Fractures: A Retrospective Analysis. Indian J Orthop. 2023 Feb 27;57(4):571-576. doi: 10.1007/s43465-023-00843-4. eCollection 2023 Apr.
PubMed 37006729Giuseppe R, Michele R, Luca F, Michele G, Giuseppe G, Valentina M, Giustra F, Bosco F, Camarda L. Nonmetallic tension band fixation is a viable and low-complication surgical technique in patellar fractures: a five-year retrospective study. Eur J Orthop Surg Traumatol. 2024 May;34(4):2065-2071. doi: 10.1007/s00590-024-03887-w. Epub 2024 Mar 26.
PubMed 38530504Xiang F, Xiao Y, Li D, Ma W, Chen Y, Yang Y. Tension band high-strength suture combined with absorbable cannulated screws for treating transverse patellar fractures: finite element analysis and clinical study. Front Bioeng Biotechnol. 2024 Mar 7;12:1340482. doi: 10.3389/fbioe.2024.1340482. eCollection 2024.
PubMed 38515618
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of High-Strength Suture Modified Tension Band Technique for the Treatment of Patellar Fractures
- ClinicalTrials.gov ID
- NCT07248982
- Acronym / sponsor ID
- K2025-10-005
- Conditions
- Patella Fracture
- Keywords
- Patellar Fracture, Tension Band Fixation, High-Strength Suture, Knee Function, Lysholm Score, VAS Pain Score, Prospective Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fuzhou University Affiliated Provincial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Nov 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.
This prospective cohort study aims to evaluate the clinical efficacy of high-strength suture modified tension band fixation in treating patellar fractures and compare it with traditional screw-cable tension band fixation. Adult patients (18-55 years) with AO/OTA 34-C1 or 34-C2 patellar fractures will be enrolled and followed for 12 months. Primary outcomes include Lysholm knee function score, knee range of motion (ROM), and visual analog scale (VAS) pain score at 12 months post-surgery. Secondary outcomes include fracture healing time, radiographic alignment quality, complication rates, reoperation rates, implant removal rates, SF-36 health survey scores, and patient satisfaction. No additional biological samples will be collected; data will focus on clinical, radiographic, and follow-up information.
Detailed description
Patellar fractures account for approximately 1% of all fractures and are common in knee injuries. Traditional tension band fixation is widely used but associated with issues such as hardware migration, soft tissue irritation, and postoperative pain, impacting rehabilitation and quality of life. High-strength sutures offer improved biomechanical properties, flexibility, and reduced soft tissue damage. This study observes the clinical efficacy of high-strength suture modified tension band fixation compared to traditional methods through a prospective cohort design.
Patients admitted to Fuzhou University Affiliated Provincial Hospital from February 2024 to February 2026 with patellar fractures undergoing surgery will be divided into two groups based on surgical method: Suture Fixation (SF) group and Screw-Cable Tension Band (SCTB) group. Follow-up will occur for 12 months, assessing outcomes such as postoperative VAS pain scores, Lysholm knee scores, ROM, SF-36 health surveys, surgical time, intraoperative blood loss, hospital stay, and complications (e.g., infection, fixation failure, nonunion).
General data collected includes demographics (age, gender, height, weight, BMI), comorbidities (e.g., diabetes, hypertension, smoking), ASA classification, fracture details (side, type, displacement, mechanism, time from injury), and perioperative complications. Imaging assessments include fracture reduction quality (good, satisfactory, poor) via X-ray, healing time (weeks until fracture line blurs/disappears), and patellar height via Insall-Salvati index. Muscle strength (quadriceps via MMT, 0-5 grades) and patient satisfaction (1-5 scale) will also be evaluated.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded, reported to the ethics committee, and managed promptly. Statistical analysis will use IBM SPSS Statistics 27.0, with t-tests, Mann-Whitney U tests, chi-square/Fisher's exact tests, Kaplan-Meier curves, and regressions as appropriate. Intention-to-treat (ITT) analysis will be primary, with multiple imputation for missing data.
The study is feasible given the hospital's patient volume and the principal investigator's experience. Ethical principles follow the Helsinki Declaration, with informed consent and privacy protection. Results will be published in academic journals and presented at conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture Fixation (SF) Group | – | Procedure: High-Strength Suture Modified Tension Band FixationPatients receiving high-strength suture modified tension band fixation for patellar fracture. |
| Screw-Cable Tension Band (SCTB) Group | – | Procedure: Screw-Cable Tension Band FixationPatients receiving traditional screw-cable tension band fixation for patellar fracture. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with patellar fractures seeking surgical treatment at Fuzhou University Affiliated Provincial Hospital, meeting inclusion criteria, and grouped based on surgical technique received.
Key inclusion criteria (1 listed)
- 1.Age 18-55 years. 2.Radiographically confirmed patellar fracture (AO/OTA 34-C1 or 34-C2). 3.First-time patellar fracture surgery. 4.Time from injury to surgery ≤ 2 weeks. 5.Able to comply with follow-up and provide written informed consent. 6.Normal pre-injury knee function. 7.Able to tolerate surgery and agree to surgical treatment. 8.Intact cognitive function.
Key exclusion criteria (3 listed)
- 1.Age <18 or >55 years. 2.Pathological fractures. 3.Prior patellar surgery or severe underlying patellofemoral disease. 4.Time from injury to surgery >2 weeks. 5.Concurrent active infection or severe medical conditions. 6.Severe neuropsychiatric disorders affecting follow-up compliance. 7.Postmenopausal women. 8.Inability to tolerate surgery or refusal of surgery. 9.Comorbid patellar dysplasia, rheumatoid arthritis, or other patellofemoral diseases.
- 10.Comorbid systemic or local infection at surgical site. 11.Comorbid severe lower limb or systemic injuries. 12.Pre-injury cognitive impairment, mental disorder, or independent walking disability.
- 13.Other conditions unsuitable for enrollment.
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 |
|---|---|---|
| High-Strength Suture Modified Tension Band FixationAlso: Suture Fixation (SF)Use of high-strength sutures for modified tension band fixation in patellar fracture surgery. | Procedure or surgery | Suture Fixation (SF) Group |
| Screw-Cable Tension Band FixationUse of screws and cables for traditional modified tension band fixation in patellar fracture surgery. | Procedure or surgery | Screw-Cable Tension Band (SCTB) Group |
Primary outcome
Lysholm Knee Score at 12 Months Postoperatively
Time frame: 12 months postoperatively
Lysholm knee scoring scale (0-100 points; 95-100 = excellent, 84-94 = good, 65-83 = fair, <65 = poor; higher scores indicate better knee function). Assessed at baseline (pre-injury recalled), 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
Knee Range of Motion at 12 Months Postoperatively
Time frame: 12 months postoperatively
Active knee flexion and extension range of motion measured in degrees with a goniometer (higher values indicate better function). Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
Visual Analog Scale (VAS) Pain Score at 12 Months Postoperatively
Time frame: 12 months postoperatively
Visual Analog Scale for pain (0-10 points; 0 = no pain, 10 = worst imaginable pain; higher scores indicate more severe pain). Assessed preoperatively and at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
11 secondary outcomes
Fracture Healing Time
Time frame: Assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively or until healing confirmed
Radiographic Alignment Quality
Time frame: Immediately postoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively
Complication Rate
Time frame: From surgery to 12 months postoperatively
Reoperation Rate
Time frame: From surgery to 12 months postoperatively
Implant Removal Rate
Time frame: From surgery to 12 months postoperatively
SF-36 (36-Item Short Form Health Survey) Score
Time frame: 12 months postoperatively
Surgical Time
Time frame: Day of surgery
Intraoperative Blood Loss
Time frame: Day of surgery
Hospital Stay Duration
Time frame: From day of surgery to discharge
Quadriceps Muscle Strength (Manual Muscle Testing)
Time frame: Assessed at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively
Patellar Height (Insall-Salvati Index)
Time frame: Assessed at 1 month, 3 months, 6 months, and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 35701245Adjal J, Haugaard A, Vesterby L, Ibrahim HM, Sert K, Thomsen MG, Tengberg PT, Ban I, Ohrt-Nissen S. Suture tension band fixation vs. metallic tension band wiring for patella fractures - A biomechanical study on 19 human cadaveric patellae. Injury. 2022 Aug;53(8):2749-2753. doi: 10.1016/j.injury.2022.05.015. Epub 2022 May 26.
- Background: PubMed 17098238Hughes SC, Stott PM, Hearnden AJ, Ripley LG. A new and effective tension-band braided polyester suture technique for transverse patellar fracture fixation. Injury. 2007 Feb;38(2):212-22. doi: 10.1016/j.injury.2006.07.013. Epub 2006 Nov 13.
- Background: PubMed 9294799Carpenter JE, Kasman RA, Patel N, Lee ML, Goldstein SA. Biomechanical evaluation of current patella fracture fixation techniques. J Orthop Trauma. 1997 Jul;11(5):351-6. doi: 10.1097/00005131-199707000-00009.
- Background: PubMed 22183197LeBrun CT, Langford JR, Sagi HC. Functional outcomes after operatively treated patella fractures. J Orthop Trauma. 2012 Jul;26(7):422-6. doi: 10.1097/BOT.0b013e318228c1a1.
- Background: PubMed 33625743Sayum Filho J, Lenza M, Tamaoki MJ, Matsunaga FT, Belloti JC. Interventions for treating fractures of the patella in adults. Cochrane Database Syst Rev. 2021 Feb 24;2(2):CD009651. doi: 10.1002/14651858.CD009651.pub3.
- Background: PubMed 37006729Huang L, Li X, Ye L, Li S. Closed Reduction and High-Strength Sutures for Transverse Patella Fractures: A Retrospective Analysis. Indian J Orthop. 2023 Feb 27;57(4):571-576. doi: 10.1007/s43465-023-00843-4. eCollection 2023 Apr.
- Background: PubMed 38530504Giuseppe R, Michele R, Luca F, Michele G, Giuseppe G, Valentina M, Giustra F, Bosco F, Camarda L. Nonmetallic tension band fixation is a viable and low-complication surgical technique in patellar fractures: a five-year retrospective study. Eur J Orthop Surg Traumatol. 2024 May;34(4):2065-2071. doi: 10.1007/s00590-024-03887-w. Epub 2024 Mar 26.
- Background: PubMed 38515618Xiang F, Xiao Y, Li D, Ma W, Chen Y, Yang Y. Tension band high-strength suture combined with absorbable cannulated screws for treating transverse patellar fractures: finite element analysis and clinical study. Front Bioeng Biotechnol. 2024 Mar 7;12:1340482. doi: 10.3389/fbioe.2024.1340482. eCollection 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only aggregated study results and summary statistics will be made available through publications and conference presentations.
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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.
Wei Xu, Dr principal investigator
Fuzhou University Affiliated Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patella Fracture, run by Fuzhou University Affiliated Provincial Hospital 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anning Liu, M.Med. (candidate) (+8615259370989, jomt852@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score at 12 Months Postoperatively (time frame: 12 months postoperatively). The study lists 3 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 NCT07248982, which also lists 8 linked publications.
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 25 Nov 2025.