Patella FractureWASPNCT06981039
Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures
A study testing Patella Anatomical Locking Plate and Tension Band Wiring in people with Patella Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures. 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?
- Patella Anatomical Locking Plate and Tension Band Wiring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Feb 2024to 31 Jul 2026
- 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
- Aged 18 years or older
- Diagnosed with an isolated closed injury, displaced, unstable fracture with displacement >2mm (AO/OTA Classification 34-B and C with surgical indication)
- Able to give consent
Who cannot join
- History of previous knee surgery
- Poly trauma,
- Ongoing malignancy
- Pre-existing severe knee osteoarthritis (>KL stage 4)
- Stroke
- Other neurological conditions/injuries to the lower limb
Show all 9Show fewer
- Unfit for surgical anaesthesia
- Non-ambulatory
- Unable to consent or follow commands
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Christian FANG, +852 22554581, cfang@hku.hk
Christian Fang
About this study
Official title: The WASP Trial (Wiring Versus Anterior Star Plate): Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures: A Randomized Controlled Trial
This study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.
Read the detailed description
Patellar fractures are a common injury that can cause significant pain and disability. Conventional treatment options frequently include tension band wiring (TBW) with or without axial K-Wires or through cannulated screws. However, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures.
More recently, plate fixation has become increasingly more prevalent in the past decade. Initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. Biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to TBW. Its low profile construct and round edges may be more tolerable to patients and less prominent than TBW. Furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in TBW. This is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. This study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.
- Conditions
- Patella Fracture
- Being tested
- Patella Anatomical Locking Plate, Tension Band Wiring
- Keywords
- trauma, knee injury, Tension Band Wiring, Patella fracture, Anatomical locking plate fixation
- Medical subject headings
- Patella Fracture, Wounds and Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patella Anatomical Locking PlateDevice
Patients in the patella anatomical locking plate group will undergo internal fixation with an anterior locking plate and screw construct using the 2.7mm variable angle (VA) locking patella plating system (DePuy Synthes, Zuchwil, Switzerland)
Tension Band WiringDevice
Patients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct.
| Study group | Role | What they receive |
|---|---|---|
| Patella Anatomical Locking Plate Group (Anterior Star Plate) | Experimental | Fracture repair surgery using the patella anatomical locking plate Receives: Device: Patella Anatomical Locking Plate |
| Tension Band Wiring Group (Wiring) | Active comparator | Fracture repair surgery with a tension band wire construct Receives: Device: Tension Band Wiring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Tegner Lysholm Knee Score
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Tegner Activity Scale
The Tegner Activity Scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Secondary outcomes (3)
Radiographic outcomes
Subjects' X-rays will be assessed for fracture healing progress.
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of Complications
Complications such as fracture site infection, implant failure, and re-operation will be assessed and recorded
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjective Implant Impingement Questionnaire
The questionnaire consists of 11 questions assessing the level of implant impingement reported by the patient, with a final score ranging from 0 (no impingement) to 20 (consistent impingement).
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start14 Feb 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (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 The University of Hong KongThe 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
- Model description
- Pragmatic, double-blind randomized controlled trial with 60 patients in two interventional arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Christian Xinshuo Fang, The University of Hong Kong
- Investigators
- Christian Fang, Principal investigator, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981039
- Sponsor's protocol ID
- UW 24-025
- Acronym
- WASP
- Status last verified
- Apr 2025
- First submitted
- 2 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset to be included as supplementary data in final publication
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WASP Trial (Wiring Versus Anterior Star Plate): Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06981039
- Acronym / sponsor ID
- WASP / UW 24-025
- Conditions
- Patella Fracture
- Keywords
- trauma, knee injury, Tension Band Wiring, Patella fracture, Anatomical locking plate fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 May 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 study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.
Detailed description
Patellar fractures are a common injury that can cause significant pain and disability. Conventional treatment options frequently include tension band wiring (TBW) with or without axial K-Wires or through cannulated screws. However, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures.
More recently, plate fixation has become increasingly more prevalent in the past decade. Initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. Biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to TBW. Its low profile construct and round edges may be more tolerable to patients and less prominent than TBW. Furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in TBW. This is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. This study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, double-blind randomized controlled trial with 60 patients in two interventional arm
| Arm | Type | Receives |
|---|---|---|
| Patella Anatomical Locking Plate Group (Anterior Star Plate) | Experimental | Device: Patella Anatomical Locking PlateFracture repair surgery using the patella anatomical locking plate |
| Tension Band Wiring Group (Wiring) | Active comparator | Device: Tension Band WiringFracture repair surgery with a tension band wire construct |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Diagnosed with an isolated closed injury, displaced, unstable fracture with displacement >2mm (AO/OTA Classification 34-B and C with surgical indication)
- Able to give consent
Key exclusion criteria (9 listed)
- History of previous knee surgery
- Poly trauma,
- Ongoing malignancy
- Pre-existing severe knee osteoarthritis (>KL stage 4)
- Stroke
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 |
|---|---|---|
| Patella Anatomical Locking PlatePatients in the patella anatomical locking plate group will undergo internal fixation with an anterior locking plate and screw construct using the 2.7mm variable angle (VA) locking patella plating system (DePuy Synthes, Zuchwil, Switzerland) | Device | Patella Anatomical Locking Plate Group (Anterior Star Plate) |
| Tension Band WiringPatients in the tension band wiring group will undergo open anatomical reduction and internal fixation with a tension band wire construct. | Device | Tension Band Wiring Group (Wiring) |
Primary outcome
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Tegner Lysholm Knee Score
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Tegner Activity Scale
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The Tegner Activity Scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
3 secondary outcomes
Radiographic outcomes
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of Complications
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Subjective Implant Impingement Questionnaire
Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
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 20 May 2025.
- Individual participant dataSharing planned: Yes. Anonymized dataset to be included as supplementary data in final publication
Related trials for Patella Fracture
Active, not recruiting
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Patella Fracture
Active, not recruitingObservational study
Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing
Anterior Knee Pain, Patellar Tendon Disorder
Not yet recruiting
Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
RecruitingObservational study
Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
Osteochondral Defect, Osteochondritis Dissecans
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.
Christian Fang principal investigator
Dept of Orthopaedics and Traumatology, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patella Anatomical Locking Plate and Tension Band Wiring in people with Patella Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 9 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 20 May 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 Hong Kong. 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 Christian FANG (+852 22554581, cfang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months). 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?
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 20 May 2025.