"Pilot study on the performance of single-stage cementless septic total hip arthroplasty (THA) with resorbable antibiotic-containing bone graft substitute."

"Pilot study on the performance of single-stage cementless septic total hip arthroplasty (THA) with resorbable antibiotic-containing bone graft substitute." - CeraHip

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024071

Enrollment

Registered

2021-02-18

Start date

2019-05-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

T84.5

Interventions

Group 1: The pilot study consists of the evaluation of a prospective patient collective with periprosthetic infections of the hip joint. Patients will be treated and followed up as part of our cente

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Age =18 consenting patients scheduled for single-stage replacement due to periprosthetic infection of the hip at CMSC who understand and sign the informed consent form for study participation.

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Evidence of problem germs (Candida, rifampicin-resistant gram-positive germs, ciprofloxacin-resistant gram-negative germs). - Fistulas - Severe bone and soft tissue involvement of the infection - Drug addiction - Severe psychiatric disorders (e.g. severe depression) - Malignant diseases under treatment and manifest dementia

Design outcomes

Primary

Measure	Time frame
Safety of bone defect reconstruction by RAKM in single-stage cementless hip replacement for periprosthetic infection, Safety of bone defect reconstruction by RAKM in single-stage cementless hip replacement for periprosthetic infection, Primary endpoint: safety - Adverse Events (AEs) - Wound secretion in days - Revision surgery Exploratory endpoints (baseline preoperative): - Harris Hip Score (HHS) week 6, 26 and 52. o Visual analog scale (VAS) postop. Day 1, 2, 5, 7, 14, Week 6, 26 and 52. - Pain medication consumption postop. Day 1, 2, 5, 7, 14, Week 6, 26 and 52. o EQ-5D week 6, 26 and 52. - Rate of patients with reinfection by Delphi criteria at one year. Results from our patient series are compared to data in the literature.	—

Measure

Time frame

Safety of bone defect reconstruction by RAKM in single-stage cementless hip replacement for periprosthetic infection, Safety of bone defect reconstruction by RAKM in single-stage cementless hip replacement for periprosthetic infection, Primary endpoint: safety - Adverse Events (AEs) - Wound secretion in days - Revision surgery Exploratory endpoints (baseline preoperative): - Harris Hip Score (HHS) week 6, 26 and 52. o Visual analog scale (VAS) postop. Day 1, 2, 5, 7, 14, Week 6, 26 and 52. - Pain medication consumption postop. Day 1, 2, 5, 7, 14, Week 6, 26 and 52. o EQ-5D week 6, 26 and 52. - Rate of patients with reinfection by Delphi criteria at one year. Results from our patient series are compared to data in the literature.

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Secondary

Measure	Time frame
Functional assessment by Harris Hip Score; incidence of postoperative pain, assessment by visual analog scale (VAS), analgesic consumption, and descriptive EQ-5D- questionnaire; recurrence rate of infection by Delphi method.	—

Countries

Germany

Contacts

Public ContactThilo Khakzad

Charite Universitätmedizin Berlin Campus Virchow Klinikum

thilo.khakzad@charite.de030 450 65 90 96

Outcome results

None listed

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