A clinical study for evaluating patient satisfaction of wound healing and patient safety after total hip arthroplasty with transverse skin incision

A multi-center RCT on skin incision in total hip arthroplasty: OCM T-I project - OCM T-I project

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058103

Enrollment

120

Registered

2025-06-06

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip joint diseases

Interventions

Transverse skin incision for surgical approach to hip joint Longitudinal skin incision for surgical approach to hip joint

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are candidate for THA with OCM approach 2. Patients who are expected to be followed up for at least 6 months postoperatively 3. Patients who are deemed to use the following device/implants (To eliminate evaluation bias due to device/implant model): AR Hip Navigation (Surgical navigation), G7 Cup (Acetabular cup), Vivacit-E Liner (Acetabular liner), Delta Ceramic Head with over 32 mm outside diameter (Femoral head), Avenir Complete Stem (Femoral stem) 4. Patients who are deemed to use the following tool (To eliminate evaluation bias due to tool model): Steri-Strip, Mepilex (Wound dressing)

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet any of the inclusion criteria listed in 4-3-1 2. Patients with have skin diseases 3. Patients with dislocation hip 4. Patients with history of hip surgery(ies) 5. Patients who are eligible Cases a cup with 44 mm diameter or less is appropriate 6. Patients who have took THA for contralateral hip, or scheduled bilateral THA

Design outcomes

Primary

Measure	Time frame
Wound healing (Difference between groups in scar assessment scores (POSAS, JSW Scar Scale) at 12 months postoperatively)	—

Secondary

Measure	Time frame
Wound healing (Difference between groups in scar assessment scores (POSAS, JSW Scar Scale) at 3 months postoperatively and 6 months), psychological impact of wound healing (MPIS), difficulty of each skin incision (Operative time, Implant alignment), clinical assessment scores (JOA, HHS, JHEQ, FJS-12), complications, length of skin incision, necessity of additional skin incision, and effect of switching to transverse incision based on surgeon's experience with OCM approach	—

Measure

Time frame

Wound healing (Difference between groups in scar assessment scores (POSAS, JSW Scar Scale) at 3 months postoperatively and 6 months), psychological impact of wound healing (MPIS), difficulty of each skin incision (Operative time, Implant alignment), clinical assessment scores (JOA, HHS, JHEQ, FJS-12), complications, length of skin incision, necessity of additional skin incision, and effect of switching to transverse incision based on surgeon's experience with OCM approach

—

Countries

Japan

Contacts

Public ContactManabu Tsukamoto

University of Occupational and Environmental Health Department of Orthopaedic Surgery

j-seikei@mbox.med.uoeh-u.ac.jp+81-93-691-7444

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026