A Study on Skin Incision Designs in THA

JRCT ID: jRCT1062240068

Registered date:09/10/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Osteoarthritis of the hip
Rheumatoid arthritis
Osteonecrosis of the femoral head
Femoral fracture

• Date of first enrollment: 09/10/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Upon admission, randomization will be performed using stratified block randomization. During total hip arthroplasty, either a conventional longitudinal skin incision or an incision along the Langer's lines will be used. All surgeries will be performed by the same surgeon.

The conventional longitudinal incision is approximately 10 cm long, extending from the femoral greater trochanter toward the iliac crest. The incision along Langer's lines is approximately 10 cm long, centered around the inguinal crease, which can be identified by flexing the hip.

To minimize the influence of suturing techniques and materials on wound closure, these will be standardized across facilities. The fascia will be sutured using 0 monofilament absorbable sutures, while the subcutaneous fat and skin will be sutured using 3-0 monofilament absorbable sutures. Sterile adhesive strips will be applied to the epidermis.

Outcome(s)

• Primary Outcome: UNC4P; University of North Carolina '4P' scar scale

Secondary Outcome

1. Japanese Orthopaedic Association Hip Score, Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ), wound appearance and subjective symptoms, prosthesis position, incidence of heterotopic ossification, and reoperation rate.
2. Operative time.
3. Blood loss.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with osteoarthritis, rheumatoid arthritis showing joint space narrowing on plain X-rays, patients with osteonecrosis of the femoral head showing femoral head collapse on plain X-rays, or patients with femoral fractures showing fractures of the femur on plain X-rays.
2. Patients scheduled for total hip arthroplasty using the anterolateral approach.
3. Patients aged 18 years or older at the time of consent.
4. Patients who have received a sufficient explanation about the study, have fully understood it, and have provided written consent of their own free will.

Exclude criteria

1. Patients with severe deformities of the ilium due to pelvic fractures or pelvic surgery.
2. Patients using steroids, immunosuppressants, or anticancer drugs.
3. Patients with diabetes.
4. Pregnant women or women with a possibility of being pregnant.
Breastfeeding women.
5. Patients deemed unsuitable for surgery via the anterolateral approach due to body shape or bone morphology.
6. Patients judged unsuitable as study participants by the principal investigator or sub-investigators for other reasons.

Related Information

• Primary Sponsor: Tetsunaga Tomonori