An interventional study of Infrapatellar Approach and Suprapatellar Approach in Tibial Fractures and Anterior Knee Pain Syndrome, sponsored by Fraser Orthopaedic Research Society. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Fraser Orthopaedic Research Society · Not applicable, Interventional, and Treatment
This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.
The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.
This study's enrollment of 248 is above the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.
Browse Patellofemoral Pain Syndrome studies →Fraser Orthopaedic Research Society is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Procedure: Infrapatellar Approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Procedure: Suprapatellar Approach
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
VAS (visual analog scale) for pain on kneeling/ability to knee
Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale
Time frame: 12 months post treatment
AKT (Aberdeen Kneeling Weight-Distribution Test)
The AKT involves kneeling on two separate calibrated scales for up to 60 seconds with the patient blinded to the readings. At 15-second intervals the weight distribution, measured in kg, between the two knees is documented.
Time frame: 4, 6, 12 and 24 months post treatment
AST (Aberdeen Standing Weight-Distribution Test)
The AST involves the patient standing on two separate calibrated scales (one foot on each scale) and the weight in kg recorded with the patient blinded to the readings.
Time frame: 4, 6, 12 and 24 months post treatment
VAS (Visual Analog Scale) at rest, with walking and descending stairs
Participants overall assessment of their pain at rest, with walking and descending stairs over the past week on a 10 cm visual analog scale
Time frame: 4, 6, 12 and 24 months post treatment
Lysholm Knee Scoring Scale
Used to evaluate outcomes of knee ligament surgery using 8-items commonly affecting patients with anterior knee pain: Limp, support, locking, instability, pain, swelling, stair climbing and squatting.
Time frame: 4, 6, 12 and 24 months post treatment
PKPM (Photographic knee pain map)
Used to determine the precise location of the knee pain, as indicated and localized by the participant.
Time frame: 4, 6,12 and 24 months post treatment
EQ-5D Health Related Quality of Life Outcome Measure
5 dimensions: Mobility: self-care, usual activities, pain/discomfort and anxiety/depression
Time frame: 4, 6,12 and 24 months post treatment
WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem
A questionnaire pertaining to the effect of the participants tibial fracture on their ability to work and perform regular activities.
Time frame: 4, 6, 12 and 24 months post treatment
Radiographic outcome
Blinded independent reviewer will adjudicate alignment, nail position and determination of union at one year, as well as change of position of the nail.
Time frame: Intra-operatively and 4, 6,12 and 24 months post treatment
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fraser Orthopaedic Research Society