Total Hip Arthroplasty (THA)
Conditions
Brief summary
Randomized, prospective, single-blind clinical trial comparing two static wound retractors - the Charnley retractor and the Alexis O-Ring retractor - in primary total hip arthroplasty (THA). The primary objective is to compare surgical site contamination rates between the two devices. Secondary objectives include comparison of incision length, surgical time, intraoperative skin lesions, and postoperative complications including periprosthetic joint infection. Patients will be randomized 1:1 to either retractor group. Surgical site contamination will be assessed through four intraoperative cultures taken at standardized timepoints. Follow-up will be conducted at 1 month postoperatively.
Interventions
Circular polyurethane wound retractor (Applied Medical, Rancho Santa Margarita, CA, USA). A rigid deep ring is placed beneath the fascia lata, and the polyurethane cylinder is rolled around the outer ring to retract wound edges and create a physical barrier between the skin and the surgical field.
DEVICECharnley Retractor
Semi-rigid stainless steel ortostatic retractor consisting of a bow with two blades (one fixed, one adjustable). Placed around the incision at the level of the fascia lata to retract wound edges through elastic tension. Standard retractor currently used in total hip arthroplasty.
Sponsors
Hospital del Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with symptomatic hip osteoarthritis indicated for primary total hip arthroplasty (THA)
Exclusion criteria
* Previous surgical interventions or scar tissue over the hip to be operated Subcapital femoral fractures requiring THA (non-primary indication) History of infection in any previous joint arthroplasty procedure Immunological disorders increasing the risk of periprosthetic joint infection (diagnosed immunodeficiencies, chemotherapy or immunosuppressive treatment) Advanced dementia or severe cognitive impairment precluding informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site contamination rate | Intraoperative | Intraoperative surgical site contamination assessed through four standardized cultures: (1) subcutaneous tissue immediately after incision, (2) deep tissue (joint capsule) before arthrotomy, (3) deep tissue after placement of definitive prosthetic components, and (4) subcutaneous tissue after retractor removal. |
Countries
Spain
Outcome results
None listed