Inferior Patellar FractureNCT06736639
Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite Element Analysis Combined with a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment
An observational study of Inferior Patellar Fracture and Fracture Maps, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (IPPF): anchor suture with patellar cerclage and Kirschner-wire tension band combined with patellar cerclage. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Patellar Fracture, Fracture Maps, Finite Element Analysis
- What is being tested?
- Anchor Suture with Titanium Cable Cerclage and Kirschner wire tension band + cerclage cable
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 2 Sep 2024
- Phase
- Observational
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients diagnosed with inferior pole patellar fractures (IPPF), confirmed through X-ray or CT imaging, and aged between 18 and 70 years. Eligible participants include individuals with isolated inferior pole patellar fractures who meet the inclusion criteria. Patients with concomitant fractures of other parts of the knee, open fractures, or pathological fractures are excluded to ensure a homogenous study population. This population represents a clinically relevant group for evaluating the outcomes of surgical interventions for IPPF.
Who may be able to join
- diagnosis of IPPF confirmed by X-ray or CT, and (2) patients aged between 18 and 70 years.
Who cannot join
- concomitant fractures of other parts of the knee, (2) open fractures, and (3) pathological fractures.
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
The goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (IPPF): anchor suture with patellar cerclage and Kirschner-wire tension band combined with patellar cerclage. The study involves patients with IPPF, focusing on fracture patterns and treatment outcomes.
- Undergo retrospective analysis of fracture patterns using fracture mapping.
- Participate in biomechanical analysis via finite element modeling of both treatment methods.
- Be part of a clinical comparison between two surgical treatments based on operative time, postoperative complications, and functional outcomes.
- Being tested
- Anchor Suture with Titanium Cable Cerclage, Kirschner wire tension band + cerclage cable
- Keywords
- Inferior Patellar Fracture, Fracture Maps, Finite Element Analysis, Retrospective Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anchor Suture with Titanium Cable CerclageProcedure or surgery
This intervention involves the use of anchor suture fixation combined with titanium cable cerclage for the treatment of inferior pole patellar fractures (IPPF). The anchor suture provides stable fixation of fracture fragments by anchoring directly into the bone, while the titanium cable cerclage offers additional reinforcement around the patella to enhance stability and minimize fragment displacement. This method is specifically designed to address the limitations of traditional Kirschner-wire tension band techniques, such as hardware irritation and infection, by using biocompatible and low-profile materials.
Kirschner wire tension band + cerclage cableProcedure or surgery
This intervention uses Kirschner wire tension band combined with cerclage cable to treat inferior pole patellar fractures (IPPF). The Kirschner wires are positioned across the fracture site to form a tension band, which transforms tensile forces into compressive forces, promoting fracture stability. The cerclage cable is added to reinforce the fixation by encircling the patella, providing additional stability to comminuted or complex fractures.
| Study group | Role | What they receive |
|---|---|---|
| Anchor + titanium cable cerclage (ISB-LP) | This group includes patients with inferior pole patellar fractures (IPPF) treated using anchor suture fixation combined with titanium cable cerclage. The intervention involves securing fracture fragments with anchors to provide stable fixation, reinforced by a titanium cable cerclage for additional stability. This method is intended to reduce hardware-related complications while maintaining biomechanical stability and supporting functional recovery. The outcomes for this group include operative time, postoperative knee range of motion, incidence of complications, need for secondary surgery, and functional scores such as the Bostman score. Receives: Procedure: Anchor Suture with Titanium Cable Cerclage | |
| TBW-LP fixed (TBW-LP group) | This group includes patients with inferior pole patellar fractures (IPPF) treated using Kirschner-wire tension band combined with patellar cerclage (TBW-LP group). This intervention involves the placement of Kirschner wires to create a tension band construct across the fracture site, stabilizing the fragments, with additional support provided by a cerclage wire. This method is widely used in clinical practice due to its simplicity and cost-effectiveness. The study evaluates key outcomes for this group, including operative time, knee range of motion, incidence of postoperative complications such as hardware irritation or infection, and functional recovery based on Bostman scores. This group serves as a comparison to newer techniques like anchor suture with titanium cable cerclage. Receives: Procedure: Kirschner wire tension band + cerclage cable |
What is being measured
The primary outcome is the main question the study is designed to answer.
final knee range of motion
The final knee range of motion is assessed to evaluate the functional recovery of patients following surgical treatment for inferior pole patellar fractures (IPPF). This measure includes the degree of flexion and extension achieved during follow-up, as documented through physical examination and patient self-reports. The range of motion is compared between the two intervention groups to determine the effectiveness of each treatment method in restoring knee functionality and mobility. Outcomes are measured and analyzed based on clinical standards and benchmarks for knee rehabilitation.
Measured: 6 months to 1.5 years after surgery
incidence of secondary surgery
The incidence of secondary surgery is defined as the number of patients who require an additional surgical procedure related to the treatment of inferior pole patellar fractures (IPPF) within the follow-up period. This includes procedures to address complications such as hardware irritation, infection, nonunion, malunion, or mechanical failure of the initial fixation. The data will be compared between the two intervention groups to evaluate the durability and long-term effectiveness of each surgical technique. This measure provides critical insights into the need for re-intervention and overall treatment success.
Measured: 6 months to 1.5 years after surgery
postoperative complications
Postoperative complications include any adverse events or clinical issues occurring as a result of the surgical treatment for inferior pole patellar fractures (IPPF) within the follow-up period. These complications may include, but are not limited to, hardware irritation, infection, wound dehiscence, delayed union, nonunion, or malunion. Data will be collected from medical records and follow-up visits to identify the frequency and types of complications in each intervention group. The results will be analyzed to compare the safety profiles of the anchor suture with titanium cable cerclage and the Kirschner wire tension band with cerclage cable techniques. This outcome is critical for assessing the overall safety and effectiveness of each surgical approach.
Measured: 6 months to 1.5 years after surgery
Secondary outcomes (2)
operative time
Operative time is defined as the total duration of the surgical procedure, measured from the initial incision to the completion of wound closure. This outcome measure evaluates the efficiency of the surgical intervention and provides insights into the complexity and technical demands of each technique. Operative time is compared between the two groups (anchor suture with titanium cable cerclage vs. Kirschner wire tension band with cerclage cable) to assess any significant differences in surgical duration. This metric is particularly relevant in evaluating the practicality and feasibility of each intervention in clinical practice.
Measured: 6 months to 1.5 years after surgery
functional recovery
Functional recovery is evaluated using validated scoring systems, such as the Bostman score, to assess the restoration of knee function following surgical treatment for inferior pole patellar fractures (IPPF). This measure includes parameters such as pain levels, range of motion, ability to perform daily activities, and overall patient satisfaction. Data will be collected during follow-up visits to determine the extent of functional improvement and to compare outcomes between the two intervention groups (anchor suture with titanium cable cerclage vs. Kirschner wire tension band with cerclage cable). This outcome provides critical insights into the effectiveness of each surgical technique in achieving optimal rehabilitation and long-term knee function.
Measured: 6 months to 1.5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Aug 2024
- Primary completion31 Aug 2024
- Study completion2 Sep 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 Inferior Patellar 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 57 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
- NCT06736639
- Sponsor's protocol ID
- JD-HG-2024-064
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hu Z, Sun C, Heng H, Li J, Chen H, Chen F, Su P, Wang D. Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite-Element Analysis Combined With a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment. Orthop Surg. 2025 Apr;17(4):1045-1056. doi: 10.1111/os.14351. Epub 2025 Jan 22.
PubMed 39844589
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite Element Analysis Combined with a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment
- ClinicalTrials.gov ID
- NCT06736639
- Acronym / sponsor ID
- JD-HG-2024-064
- Keywords
- Inferior Patellar Fracture, Fracture Maps, Finite Element Analysis, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 17 Dec 2024 (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.
The goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (IPPF): anchor suture with patellar cerclage and Kirschner-wire tension band combined with patellar cerclage. The study involves patients with IPPF, focusing on fracture patterns and treatment outcomes.
- Undergo retrospective analysis of fracture patterns using fracture mapping.
- Participate in biomechanical analysis via finite element modeling of both treatment methods.
- Be part of a clinical comparison between two surgical treatments based on operative time, postoperative complications, and functional outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anchor + titanium cable cerclage (ISB-LP) | – | Procedure: Anchor Suture with Titanium Cable CerclageThis group includes patients with inferior pole patellar fractures (IPPF) treated using anchor suture fixation combined with titanium cable cerclage. The intervention involves securing fracture fragments with anchors to provide stable fixation, reinforced by a titanium cable cerclage for additional stability. This method is intended to reduce hardware-related complications while maintaining biomechanical stability and supporting functional recovery. The outcomes for this group include operative time, postoperative knee range of motion, incidence of complications, need for secondary surgery, and functional scores such as the Bostman score. |
| TBW-LP fixed (TBW-LP group) | – | Procedure: Kirschner wire tension band + cerclage cableThis group includes patients with inferior pole patellar fractures (IPPF) treated using Kirschner-wire tension band combined with patellar cerclage (TBW-LP group). This intervention involves the placement of Kirschner wires to create a tension band construct across the fracture site, stabilizing the fragments, with additional support provided by a cerclage wire. This method is widely used in clinical practice due to its simplicity and cost-effectiveness. The study evaluates key outcomes for this group, including operative time, knee range of motion, incidence of postoperative complications such as hardware irritation or infection, and functional recovery based on Bostman scores. This group serves as a comparison to newer techniques like anchor suture with titanium cable cerclage. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with inferior pole patellar fractures (IPPF), confirmed through X-ray or CT imaging, and aged between 18 and 70 years. Eligible participants include individuals with isolated inferior pole patellar fractures who meet the inclusion criteria. Patients with concomitant fractures of other parts of the knee, open fractures, or pathological fractures are excluded to ensure a homogenous study population. This population represents a clinically relevant group for evaluating the outcomes of surgical interventions for IPPF.
Key inclusion criteria (1 listed)
- diagnosis of IPPF confirmed by X-ray or CT, and (2) patients aged between 18 and 70 years.
Key exclusion criteria (1 listed)
- concomitant fractures of other parts of the knee, (2) open fractures, and (3) pathological fractures.
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 |
|---|---|---|
| Anchor Suture with Titanium Cable CerclageThis intervention involves the use of anchor suture fixation combined with titanium cable cerclage for the treatment of inferior pole patellar fractures (IPPF). The anchor suture provides stable fixation of fracture fragments by anchoring directly into the bone, while the titanium cable cerclage offers additional reinforcement around the patella to enhance stability and minimize fragment displacement. This method is specifically designed to address the limitations of traditional Kirschner-wire tension band techniques, such as hardware irritation and infection, by using biocompatible and low-profile materials. | Procedure or surgery | Anchor + titanium cable cerclage (ISB-LP) |
| Kirschner wire tension band + cerclage cableThis intervention uses Kirschner wire tension band combined with cerclage cable to treat inferior pole patellar fractures (IPPF). The Kirschner wires are positioned across the fracture site to form a tension band, which transforms tensile forces into compressive forces, promoting fracture stability. The cerclage cable is added to reinforce the fixation by encircling the patella, providing additional stability to comminuted or complex fractures. | Procedure or surgery | TBW-LP fixed (TBW-LP group) |
Primary outcome
final knee range of motion
Time frame: 6 months to 1.5 years after surgery
The final knee range of motion is assessed to evaluate the functional recovery of patients following surgical treatment for inferior pole patellar fractures (IPPF). This measure includes the degree of flexion and extension achieved during follow-up, as documented through physical examination and patient self-reports. The range of motion is compared between the two intervention groups to determine the effectiveness of each treatment method in restoring knee functionality and mobility. Outcomes are measured and analyzed based on clinical standards and benchmarks for knee rehabilitation.
incidence of secondary surgery
Time frame: 6 months to 1.5 years after surgery
The incidence of secondary surgery is defined as the number of patients who require an additional surgical procedure related to the treatment of inferior pole patellar fractures (IPPF) within the follow-up period. This includes procedures to address complications such as hardware irritation, infection, nonunion, malunion, or mechanical failure of the initial fixation. The data will be compared between the two intervention groups to evaluate the durability and long-term effectiveness of each surgical technique. This measure provides critical insights into the need for re-intervention and overall treatment success.
postoperative complications
Time frame: 6 months to 1.5 years after surgery
Postoperative complications include any adverse events or clinical issues occurring as a result of the surgical treatment for inferior pole patellar fractures (IPPF) within the follow-up period. These complications may include, but are not limited to, hardware irritation, infection, wound dehiscence, delayed union, nonunion, or malunion. Data will be collected from medical records and follow-up visits to identify the frequency and types of complications in each intervention group. The results will be analyzed to compare the safety profiles of the anchor suture with titanium cable cerclage and the Kirschner wire tension band with cerclage cable techniques. This outcome is critical for assessing the overall safety and effectiveness of each surgical approach.
2 secondary outcomes
operative time
Time frame: 6 months to 1.5 years after surgery
functional recovery
Time frame: 6 months to 1.5 years after 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 17 Dec 2024.
- Derived from this study: PubMed 39844589Hu Z, Sun C, Heng H, Li J, Chen H, Chen F, Su P, Wang D. Morphological Characteristics of Inferior Pole Patellar Fractures and a Finite-Element Analysis Combined With a Retrospective Clinical Study of Anchor Suture and Titanium Cable Cerclage Treatment. Orthop Surg. 2025 Apr;17(4):1045-1056. doi: 10.1111/os.14351. Epub 2025 Jan 22.
- Individual participant dataSharing planned: Yes
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?
An observational study of Inferior Patellar Fracture and Fracture Maps, 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 1 inclusion and 1 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 17 Dec 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 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?
final knee range of motion (time frame: 6 months to 1.5 years after surgery). 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 NCT06736639, 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 17 Dec 2024.