Patella FractureNCT07911956
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
A study testing K-wire Tension Band Wiring and Transosseous Suture Fixation in people with Patella Fracture, run by Ain Shams University at 1 site in Egypt.
Trial summary
A transverse patellar fracture is a break across the kneecap that can affect knee movement, walking, and daily activities. Surgery is often needed to restore the position of the broken bone and allow it to heal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patella Fracture
- What is being tested?
- K-wire Tension Band Wiring and Transosseous Suture Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Acute (less than 2 weeks) closed transverse patellar fracture (AO/OTA 34-C1 or similar).
- Medically fit for surgery and anesthesia.
- Willing and able to provide informed consent and comply with the study follow-up requirements.
Who cannot join
- Age < 18 years.
- Open patellar fractures.
- Pathological fractures.
- Non-transverse fracture patterns (e.g., polar or stellate fractures).
- Previous ipsilateral knee surgery or significant knee arthritis.
- Associated major lower-limb trauma (e.g., ipsilateral femoral or tibial fracture).
- Neuromuscular disorders affecting the lower limb.
- Severe systemic illness contraindicating surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Hospitals (Demerdash Hospital)
Cairo, Cairo Governorate, 11252
About this study
Official title: Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial.
A transverse patellar fracture is a break across the kneecap that can affect knee movement, walking, and daily activities. Surgery is often needed to restore the position of the broken bone and allow it to heal.
This study will compare two surgical techniques for treating transverse patellar fractures in adults: K-wire tension band wiring and transosseous suture fixation using No. 5 FiberWire. The purpose is to determine whether the two techniques differ in knee function, fracture healing, and the occurrence of complications.
Read more
Eligible adults with an acute, closed transverse patellar fracture will be randomly assigned to one of the two treatment groups. Participants will be followed for 12 months after surgery. Knee function will be assessed using the Bostman score, while other outcomes will include pain, knee range of motion, quadriceps muscle strength, fracture healing, and complications such as infection, hardware irritation, and the need for further surgery.
The findings may help improve understanding of the benefits and limitations of these two surgical techniques and support clinical decision-making for adults with transverse patellar fractures.
Read the detailed description
Transverse patellar fractures can disrupt the extensor mechanism of the knee and impair knee function. Surgical treatment aims to restore the anatomical alignment of the patella, provide sufficient stability for fracture healing, and facilitate the recovery of knee movement and quadriceps function.
K-wire tension band wiring is a commonly used fixation technique for patellar fractures. It uses Kirschner wires and a tension band construct to stabilize the fracture. However, complications such as hardware prominence, soft-tissue irritation, infection, and the need for subsequent implant removal may occur.
Transosseous suture fixation is an alternative technique that uses sutures passed through bone tunnels to stabilize the fracture. High-strength sutures, such as No. 5 FiberWire, may provide fixation without leaving prominent metallic implants. Nevertheless, the functional outcomes and complication profiles of this technique compared with conventional K-wire tension band wiring require further evaluation.
This randomized controlled trial will compare these two surgical techniques in adults undergoing operative treatment for acute, closed transverse patellar fractures. The study will assess postoperative knee function and recovery, fracture healing, pain, range of motion, quadriceps muscle strength, and treatment-related complications during follow-up.
The study is intended to provide comparative clinical evidence regarding functional recovery, fracture union, and complications associated with the two fixation methods. The findings may help inform surgical decision-making and contribute to the selection of an appropriate fixation technique for patients with transverse patellar fractures.
- Conditions
- Patella Fracture
- Being tested
- K-wire Tension Band Wiring, Transosseous Suture Fixation
- Keywords
- Transverse Patellar Fracture, Patellar Fracture Fixation, K-wire Tension Band Wiring, Tension Band Wiring, Transosseous Suture Fixation, FiberWire, Randomized Controlled Trial, Knee Function, Fracture Healing, Postoperative Complications
- Medical subject headings
- Patella Fracture, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-wire Tension Band WiringProcedure or surgery
Surgical fixation of an acute transverse patellar fracture using Kirschner wires (K-wires) and a tension band construct to stabilize the fracture and maintain reduction during bone healing.
Transosseous Suture FixationProcedure or surgery
Surgical fixation of an acute transverse patellar fracture using transosseous bone tunnels and high-strength No. 5 FiberWire sutures to stabilize the fracture and maintain reduction during bone healing.
| Study group | Role | What they receive |
|---|---|---|
| K-wire Tension Band Wiring | Active comparator | K-wire tension band wiring for transverse patellar fracture fixation. Receives: Procedure: K-wire Tension Band Wiring |
| Transosseous Suture Fixation | Active comparator | Transosseous suture fixation using No. 5 FiberWire for transverse patellar fracture fixation. Receives: Procedure: Transosseous Suture Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome Assessed Using the Böstman Patellar Fracture Score at 12 Months
Functional outcome will be assessed using the Böstman Patellar Fracture Score, a validated scoring system for evaluating functional recovery following patellar fractures. The scale ranges from 0 to 30 points, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better functional outcomes, whereas lower scores indicate poorer functional recovery.
Measured: 12 months after surgery
Secondary outcomes (4)
Pain Severity Assessed Using the Visual Analog Scale (VAS)
Pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and worse outcomes, whereas lower scores indicate less pain and better outcomes.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
Knee Range of Motion
Knee range of motion will be assessed by measuring active knee flexion and extension using a standard goniometer. Measurements will be recorded in degrees (°). Knee flexion ranges from 0° to 140°, with higher flexion values indicating greater knee mobility and better functional recovery. Knee extension is assessed by measuring the degree of extension deficit, where 0° indicates full extension and higher deficit values indicate worse outcomes.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
Time to Fracture Union
Time to fracture union will be assessed in weeks from the date of surgery until radiographic evidence of fracture union is achieved. Fracture union will be defined by radiographic evidence of bridging bone across at least three of the four cortices on orthogonal radiographic views, in conjunction with clinical evidence of healing. The minimum value is 0 weeks. Higher values indicate a longer time to fracture union and therefore a worse outcome, whereas lower values indicate faster fracture healing and a better outcome.
Measured: Up to 12 months after surgery.
Incidence of Postoperative Complications
Postoperative complications will be assessed by recording the occurrence of any complications following surgery, including surgical site infection, wound complications, implant-related complications (such as K-wire migration, wire breakage, or fixation failure), loss of fracture reduction, nonunion, delayed union, symptomatic hardware, and reoperation. The outcome will be recorded as a binary variable: 0 = No postoperative complications and 1 = At least one postoperative complication. The minimum value is 0 and the maximum value is 1. Higher scores indicate the occurrence of postoperative complications and therefore worse outcomes.
Measured: From the date of surgery through 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 posted3 Nov 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella FractureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911956
- Sponsor's protocol ID
- ASU-PATELLA FRACTURE -RCT-2026
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The study data will be used for the purposes of the planned statistical analyses, thesis preparation, and scientific publication. Only aggregate, de-identified results will be reported in publications and presentations. This decision is intended to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07911956
- Acronym / sponsor ID
- ASU-PATELLA FRACTURE -RCT-2026
- Conditions
- Patella Fracture
- Keywords
- Transverse Patellar Fracture, Patellar Fracture Fixation, K-wire Tension Band Wiring, Tension Band Wiring, Transosseous Suture Fixation, FiberWire, Randomized Controlled Trial, Knee Function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
A transverse patellar fracture is a break across the kneecap that can affect knee movement, walking, and daily activities. Surgery is often needed to restore the position of the broken bone and allow it to heal.
This study will compare two surgical techniques for treating transverse patellar fractures in adults: K-wire tension band wiring and transosseous suture fixation using No. 5 FiberWire. The purpose is to determine whether the two techniques differ in knee function, fracture healing, and the occurrence of complications.
Eligible adults with an acute, closed transverse patellar fracture will be randomly assigned to one of the two treatment groups. Participants will be followed for 12 months after surgery. Knee function will be assessed using the Bostman score, while other outcomes will include pain, knee range of motion, quadriceps muscle strength, fracture healing, and complications such as infection, hardware irritation, and the need for further surgery.
The findings may help improve understanding of the benefits and limitations of these two surgical techniques and support clinical decision-making for adults with transverse patellar fractures.
Detailed description
Transverse patellar fractures can disrupt the extensor mechanism of the knee and impair knee function. Surgical treatment aims to restore the anatomical alignment of the patella, provide sufficient stability for fracture healing, and facilitate the recovery of knee movement and quadriceps function.
K-wire tension band wiring is a commonly used fixation technique for patellar fractures. It uses Kirschner wires and a tension band construct to stabilize the fracture. However, complications such as hardware prominence, soft-tissue irritation, infection, and the need for subsequent implant removal may occur.
Transosseous suture fixation is an alternative technique that uses sutures passed through bone tunnels to stabilize the fracture. High-strength sutures, such as No. 5 FiberWire, may provide fixation without leaving prominent metallic implants. Nevertheless, the functional outcomes and complication profiles of this technique compared with conventional K-wire tension band wiring require further evaluation.
This randomized controlled trial will compare these two surgical techniques in adults undergoing operative treatment for acute, closed transverse patellar fractures. The study will assess postoperative knee function and recovery, fracture healing, pain, range of motion, quadriceps muscle strength, and treatment-related complications during follow-up.
The study is intended to provide comparative clinical evidence regarding functional recovery, fracture union, and complications associated with the two fixation methods. The findings may help inform surgical decision-making and contribute to the selection of an appropriate fixation technique for patients with transverse patellar fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-wire Tension Band Wiring | Active comparator | Procedure: K-wire Tension Band WiringK-wire tension band wiring for transverse patellar fracture fixation. |
| Transosseous Suture Fixation | Active comparator | Procedure: Transosseous Suture FixationTransosseous suture fixation using No. 5 FiberWire for transverse patellar fracture fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Acute (less than 2 weeks) closed transverse patellar fracture (AO/OTA 34-C1 or similar).
- Medically fit for surgery and anesthesia.
- Willing and able to provide informed consent and comply with the study follow-up requirements.
Key exclusion criteria (8 listed)
- Age < 18 years.
- Open patellar fractures.
- Pathological fractures.
- Non-transverse fracture patterns (e.g., polar or stellate fractures).
- Previous ipsilateral knee surgery or significant knee arthritis.
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 |
|---|---|---|
| K-wire Tension Band WiringSurgical fixation of an acute transverse patellar fracture using Kirschner wires (K-wires) and a tension band construct to stabilize the fracture and maintain reduction during bone healing. | Procedure or surgery | K-wire Tension Band Wiring |
| Transosseous Suture FixationSurgical fixation of an acute transverse patellar fracture using transosseous bone tunnels and high-strength No. 5 FiberWire sutures to stabilize the fracture and maintain reduction during bone healing. | Procedure or surgery | Transosseous Suture Fixation |
Primary outcome
Functional Outcome Assessed Using the Böstman Patellar Fracture Score at 12 Months
Time frame: 12 months after surgery
Functional outcome will be assessed using the Böstman Patellar Fracture Score, a validated scoring system for evaluating functional recovery following patellar fractures. The scale ranges from 0 to 30 points, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better functional outcomes, whereas lower scores indicate poorer functional recovery.
4 secondary outcomes
Pain Severity Assessed Using the Visual Analog Scale (VAS)
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
Knee Range of Motion
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery.
Time to Fracture Union
Time frame: Up to 12 months after surgery.
Incidence of Postoperative Complications
Time frame: From the date of surgery through 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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The study data will be used for the purposes of the planned statistical analyses, thesis preparation, and scientific publication. Only aggregate, de-identified results will be reported in publications and presentations. This decision is intended to protect participant confidentiality and privacy.
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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.
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 K-wire Tension Band Wiring and Transosseous Suture Fixation in people with Patella Fracture, run by Ain Shams 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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?
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?
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?
Functional Outcome Assessed Using the Böstman Patellar Fracture Score at 12 Months (time frame: 12 months after surgery). 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 3 Nov 2026.