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Clinical Trials/NCT07514598
NCT07514598CompletedNot Applicable

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

Fatih Sultan Mehmet Training and Research Hospital1 site in 1 country62 target enrollmentStarted: September 17, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
62
Locations
1

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Masking was not feasible due to the visible nature of the surgical incision during postoperative assessments. Therefore, surgeons, participants, and outcome assessors were not blinded to group allocation.

Eligibility Criteria

Ages
56 Years to 81 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Fatih Sultan Mehmet Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olcay Yavuz

Medical Doctor, Orthopedic Surgery Resident

Fatih Sultan Mehmet Training and Research Hospital

Study Sites (1)

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