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Completed

NCT Number: NCT07514598

Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA)

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.

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Key information

Age range

56 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Ataşehir, Istanbul, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Midline Incision

Procedure

A conventional midline skin incision is used during primary total knee arthroplasty.

Other names: Standard midline incision

J-shaped Incision

Procedure

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: Modified J-shaped incision

Primary outcomes

  1. Area of peri-incisional sensory loss

    Time frame: 2 months and 6 months postoperatively

    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.

Secondary outcomes

  1. Postoperative pain

    Time frame: 2 months and 6 months postoperatively

    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.

  2. Range of motion

    Time frame: 2 months and 6 months postoperatively

    Knee range of motion will be measured clinically in degrees.

  3. Intraoperative Blood Loss

    Time frame: Intraoperative period

    Intraoperative blood loss will be recorded during the surgical procedure. Blood loss will be measured in milliliters (mL). Higher values indicate greater blood loss.

  4. Tourniquet Time

    Time frame: Intraoperative period

    Tourniquet time will be recorded during the surgical procedure. Tourniquet time will be measured in minutes. Higher values indicate longer tourniquet use.

  5. Incision Length

    Time frame: Intraoperative period

    Incision length will be measured intraoperatively in centimeters (cm). Higher values indicate a longer skin incision.

  6. Wound complications

    Time frame: Up to 6 months postoperatively

    Postoperative wound-related complications will be assessed clinically.

  7. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

    Time frame: 2 months and 6 months postoperatively

    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.

  8. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 months and 6 months postoperatively

    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.

  9. Hospital for Special Surgery (HSS) Knee Score

    Time frame: 2 months and 6 months postoperatively

    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.

  10. Kujala Anterior Knee Pain Scale Score

    Time frame: 2 months and 6 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

J-Shaped Incision Reduces Peri-incisional Numbness and Pain After Primary Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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