Evaluation of Arthroplasty Treatment

NCT07799818 | Recruiting

• 1 other identifier: EndoGEP2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine patients after knee and hip endoprosthesis in the longitudinal section and to evaluate the surgical outcome.

Conditions

Surgery; Knee Arthropathy; Hip Arthropathy; Prosthetic-joint Infection

Keywords

Joint prostheses; Joint surgery; Knee; Hip

Outcome Measures

Primary Outcomes (5)

• SF 12 Questionnaire

  Health-related quality of life assessed by the SF-12 (score for physical components (PCS) and total score for mental components (MCS) - higher values mean better health, lower values mean worse health with a statistical mean of the total score of 50 (SD 10) (1-100)

  preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

• Hand-held dynamometer

  Hand grip force using a hand dynamometer in absolute values (in kg).

  preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

• Dual-Energy X-Ray Absorptiometry

  Bone density values by DXA measurement (T- or Z-values as deviation of the measured value from predefined mean values. T-Score ≤ -1 = osteopenia; T-Score ≤ -2,5 = osteoporosis.

  preoperative (approx. 1Day)

• Dual-Energy X-Ray Absorptiometry

  Body composition in relation to the lean mass. Fat Mass and Lean mass (gram).

  preoperative (approx. 1Day)

• Dual-Energy X-Ray Absorptiometry

  Fat Mass in percent.

  preoperative (approx. 1Day)

Secondary Outcomes (5)

• Joint examination (HJHS)

  preoperative (approx. 1Day)

• Hip examination (Harris Hip Score)

  preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

• Knee examination (Knee Society Score)

  preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

• Blood samples

  preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative

• Biomaterial

  during operation

Study Arms (4)

Primary knee prosthesis

Patients who receive a primary knee prosthesis.

Procedure: Joint replacement

Primary hip prosthesis

Patients who receive a primary hip prosthesis.

Procedure: Joint replacement

Revision knee prosthesis

Patients who receive a revision of the knee prosthesis.

Procedure: Joint replacement

Revision hip prosthesis

Patients who receive a revision of the hip prosthesis.

Procedure: Joint replacement

Interventions

Joint replacement PROCEDURE

Patients routinely receive a joint replacement.

Also known as: Endoprothetics, Arthroplasty

Primary hip prosthesis; Primary knee prosthesis; Revision hip prosthesis; Revision knee prosthesis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this longitudinal study, subjects will be recruited from the patient population of the orthopaedic outpatient clinic of the Clinic and Polyclinic for Orthopaedics and Trauma Surgery at the University Hospital Bonn. A total of 300 patients will be included. This explorative study design is based on the number of cases and the number of operations performed in recent years at the University Hospital Bonn, which amounts to approx. 550 arthroplasty operations per year.

You may qualify if:

• There is an indication for primary knee or hip replacement or revision.
• The subject is over 18 years of age.
• Written consent is given if the subject is fully responsible.

You may not qualify if:

• A known pregnancy
• A known mental or pain-associated illness
• Illness of an airborne infectious disease with an increased risk of mortality and morbidity
• Patient intolerances or restrictions that make participation in the study impossible

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During the operation, blood, bone, cartilage, synovial fluid, synovial membrane, Hoffa's fat bodies, which are removed during the standard operation, should be preserved.

MeSH Terms

Interventions

Arthroplasty, Replacement; Arthroplasty

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Andreas C. Strauss, PD Dr. med.

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas C. Strauss, PD Dr. med.

CONTACT

+4922828714176; andreas.strauss@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: September 2, 2026
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)