An interventional study of K-wire Tension Band Wiring and Transosseous Suture Fixation in Patella Fracture, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
40 studies on the registry are indexed under Patella Fracture; 9 are open to participants now.
This study's enrollment of 30 is below the median of 53 across 30 interventional studies indexed under Patella Fracture.
Browse Patella Fracture studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
K-wire tension band wiring for transverse patellar fracture fixation.
Procedure: K-wire Tension Band Wiring
Transosseous suture fixation using No. 5 FiberWire for transverse patellar fracture fixation.
Procedure: Transosseous Suture Fixation
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.
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.
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.
Time frame: 12 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the date of surgery through 12 months postoperatively.
Plan to share: 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.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 18 interventional studies with no phase under Patella Fracture, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 136. This study's planned 12 months is below that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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