- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514598
Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA)
J-Shaped Incision Reduces Peri-incisional Numbness and Pain After Primary Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial evaluates whether a modified J-shaped skin incision can reduce peri-incisional numbness after primary total knee arthroplasty (TKA) compared with the conventional midline skin incision. Peri-incisional numbness is a common postoperative complaint after TKA and is thought to be mainly related to injury of the infrapatellar branch of the saphenous nerve. Although often considered a minor issue, it may adversely affect postoperative comfort, pain perception, and patient satisfaction.
A total of 62 patients undergoing primary TKA for Kellgren-Lawrence grade 4 varus knee osteoarthritis were randomized to either a conventional midline incision or a modified J-shaped incision. In the J-shaped technique, the distal part of the incision is curved laterally at the level of the tibial tuberosity in an effort to decrease injury to the infrapatellar branch of the saphenous nerve. The primary outcome is the extent of peri-incisional sensory loss, assessed using Semmes-Weinstein 10-g monofilament testing with a grid-mapping method before surgery and at 2 and 6 months after surgery. Secondary outcomes include pain scores, functional knee scores, range of motion, blood loss, tourniquet time, and wound-related complications.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty is an effective surgical treatment for advanced knee osteoarthritis; however, peri-incisional numbness is a frequent postoperative finding. This sensory disturbance is commonly attributed to injury of the infrapatellar branch of the saphenous nerve during the standard anterior skin incision. Although peri-incisional numbness is often not regarded as a major complication, it may negatively influence postoperative comfort and patient satisfaction and may also be associated with persistent local pain.
This study was designed to investigate whether a modified J-shaped skin incision could reduce peri-incisional numbness compared with the conventional midline incision in patients undergoing primary TKA. The underlying rationale is that altering the distal course of the skin incision laterally near the tibial tuberosity may help decrease injury to the infrapatellar branch of the saphenous nerve while preserving standard surgical exposure and not increasing operative difficulty or wound-related complications.
In this prospective randomized controlled trial, 62 patients with Kellgren-Lawrence grade 4 varus osteoarthritis scheduled for primary TKA were allocated to one of two groups: a conventional midline incision group or a modified J-shaped incision group. In the modified technique, the distal portion of the incision is curved laterally by approximately 3 cm at the level of the tibial tuberosity. All participants undergo peri-incisional sensory evaluation preoperatively and again at 2 and 6 months postoperatively. Sensory loss is quantified using Semmes-Weinstein 10-g monofilament testing combined with a grid-mapping method to determine the area of numbness.
The primary outcome measure is the area of peri-incisional numbness after surgery. Secondary outcome measures include postoperative pain assessed by visual analog scale (VAS), functional outcomes assessed by The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Hospital for Special Surgery Knee-Rating Scale (HSS) and Anterior Knee Pain Scale (AKPS) scores, range of motion, estimated blood loss, tourniquet time, and wound-related complications. These measures are intended to determine whether the modified incision provides sensory and pain-related benefits without adversely affecting clinical recovery, surgical efficiency, or wound healing.
Based on the study findings summarized in the abstract, the modified J-shaped incision was associated with a significantly smaller area of postoperative numbness at both 2 and 6 months and with lower pain scores at 6 months, while functional scores, range of motion, blood loss, tourniquet time, and wound-related complications were similar between groups. These findings support the hypothesis that a simple modification of the skin incision may improve postoperative sensory outcomes and comfort after primary TKA without increasing surgical risk.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul
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Ataşehir, Istanbul, Turkey (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults undergoing primary total knee arthroplasty
- Diagnosis of Kellgren-Lawrence grade 4 varus knee osteoarthritis
- Planned treatment with primary total knee arthroplasty
- Ability to provide written informed consent
- Ability to comply with postoperative follow-up evaluations
Exclusion Criteria:
- Valgus knee deformity
- Revision total knee arthroplasty
- Previous surgery on the affected knee
- History of periarticular fracture around the knee
- Pre-existing sensory deficit or neurologic disorder affecting the operative lower extremity
- History of lumbar disc herniation
- Known neuromuscular disease
- Peripheral vascular disease
- Inability to comply with follow-up and postoperative evaluations
- Refusal or inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Midline Incision
Participants undergo primary total knee arthroplasty using a conventional midline skin incision.
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A conventional midline skin incision is used during primary total knee arthroplasty.
Other Names:
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Experimental: J-shaped Incision
Participants undergo primary total knee arthroplasty using a modified J-shaped skin incision, in which the distal portion of the incision is curved laterally at the level of the tibial tuberosity.
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A modified J-shaped skin incision is used during primary total knee arthroplasty, in which the distal portion of the incision is curved laterally at the level of the tibial tuberosity.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Area of peri-incisional sensory loss
Time Frame: 2 months and 6 months postoperatively
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The extent of peri-incisional sensory loss will be assessed using Semmes-Weinstein 10-g monofilament testing combined with a standardized grid-mapping method to quantify the area of numbness around the surgical incision.
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2 months and 6 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain
Time Frame: 2 months and 6 months postoperatively
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Postoperative pain will be assessed using the Visual Analog Scale (VAS) for pain at 2 months and 6 months postoperatively.
The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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2 months and 6 months postoperatively
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Range of motion
Time Frame: 2 months and 6 months postoperatively
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Knee range of motion will be measured clinically in degrees.
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2 months and 6 months postoperatively
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Intraoperative Blood Loss
Time Frame: Intraoperative period
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Intraoperative blood loss will be recorded during the surgical procedure.
Blood loss will be measured in milliliters (mL).
Higher values indicate greater blood loss.
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Intraoperative period
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Tourniquet Time
Time Frame: Intraoperative period
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Tourniquet time will be recorded during the surgical procedure.
Tourniquet time will be measured in minutes.
Higher values indicate longer tourniquet use.
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Intraoperative period
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Incision Length
Time Frame: Intraoperative period
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Incision length will be measured intraoperatively in centimeters (cm).
Higher values indicate a longer skin incision.
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Intraoperative period
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Wound complications
Time Frame: Up to 6 months postoperatively
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Postoperative wound-related complications will be assessed clinically.
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Up to 6 months postoperatively
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time Frame: 2 months and 6 months postoperatively
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Functional outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 2 months and 6 months postoperatively.
If reported on a 0 to 100 scale, 0 indicates the worst symptoms/function and 100 indicates the best symptoms/function.
Higher scores indicate better outcome.
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2 months and 6 months postoperatively
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Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 2 months and 6 months postoperatively
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Functional outcome will be assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) at 2 months and 6 months postoperatively.
KOOS subscale scores range from 0 to 100, where 0 indicates extreme knee problems and 100 indicates no knee problems.
Higher scores indicate better outcome.
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2 months and 6 months postoperatively
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Hospital for Special Surgery (HSS) Knee Score
Time Frame: 2 months and 6 months postoperatively
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Functional outcome will be assessed using the Hospital for Special Surgery Knee Score (HSS) at 2 months and 6 months postoperatively.
The HSS score ranges from 0 to 100, with higher scores indicating better knee function.
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2 months and 6 months postoperatively
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Kujala Anterior Knee Pain Scale Score
Time Frame: 2 months and 6 months postoperatively
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Functional outcome will be assessed using the Kujala Anterior Knee Pain Scale at 2 months and 6 months postoperatively.
The score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.
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2 months and 6 months postoperatively
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Collaborators and Investigators
Publications and helpful links
General Publications
- James NF, Kumar AR, Wilke BK, Shi GG. Incidence of Encountering the Infrapatellar Nerve Branch of the Saphenous Nerve During a Midline Approach for Total Knee Arthroplasty. J Am Acad Orthop Surg Glob Res Rev. 2019 Dec 12;3(12):e19.00160. doi: 10.5435/JAAOSGlobal-D-19-00160. eCollection 2019 Dec.
- MacDonald B, Kurdin A, Somerville L, Ross D, MacDonald S, Lanting B. The Effect of Sensory Deficit After Total Knee Arthroplasty on Patient Satisfaction and Kneeling Ability. Arthroplast Today. 2021 Jan 11;7:264-267.e2. doi: 10.1016/j.artd.2020.11.020. eCollection 2021 Feb.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J-TKA-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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