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Evaluation of Safety and Efficiency of Two-Stage Revision of Periprosthetic Joint Infection With A High Polished Articulating Antibiotic Cement Spacer: a randomized controlled trial

Evaluation of Safety and Efficiency of Two-Stage Revision of Periprosthetic Joint Infection With A High Polished Articulating Antibiotic Cement Spacer: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038617
Enrollment
Unknown
Registered
2020-09-26
Start date
2020-09-15
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Periprosthetic Joint Infection

Interventions

High polished articulating antibiotic cement spacer group:Two-stage revision with the high polished articulating antibiotic cement spacer will be performed in hip joint
Conventional spacer group:Two-stage revision with the conventional spacer will be performed in hip joint

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18-80 years (including 18 and 80 years) with hip pain after hip arthroplasty, increased erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) and met one of the following conditions: (1) repeated purulence through the sinus of the joint cavity; (2) The results of bacterial / fungal culture in wound secretion and pus were positive; (3) the number of polymorphonuclear leukocytes was more than 5 in each high power microscopic field.

Exclusion criteria

Exclusion criteria: (1) Patients with incomplete imaging, laboratory examination results and clinical data; (2) patients with diseases that affect the motor and sensory functions of the revision side of total hip arthroplasty, such as hemiplegia of lower limbs, poliomyelitis, lumbar disc herniation; (3) patients with poor physical fitness (such as severe immune function damage, serious medical complications, etc.) who can not tolerate surgery after evaluation; (4) Patients with poor compliance, do not understand or can not cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
Harris score;Hip disability and Osteoarthritis Outcome Score;Visual Analogue Scale/Score;SF-36 scores;SF-36 score;interval time;operation time;Bone defect;Complication rate;Intraoperative blood loss;

Countries

China

Contacts

Public ContactZhong Da
dr_zhongda@126.com+86 13574890378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026