Evaluation of Arthroplasty Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital, Bonn
About this trial
The aim of the study is to examine patients after knee and hip endoprosthesis in the longitudinal section and to evaluate the surgical outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Joint replacement
Procedure/SurgeryPatients routinely receive a joint replacement.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Primary knee prosthesis1 intervention
Group B: Primary hip prosthesis1 intervention
Group C: Revision knee prosthesis1 intervention
Group D: Revision hip prosthesis1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative2
Hand-held dynamometer
Hand grip force using a hand dynamometer in absolute values (in kg).
Time frame
preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative3
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.
Time frame
preoperative (approx. 1Day)4
Dual-Energy X-Ray Absorptiometry
Body composition in relation to the lean mass. Fat Mass and Lean mass (gram).
Time frame
preoperative (approx. 1Day)Secondary outcomes
1
Joint examination (HJHS)
The hemophilia joint health score is a combined test of questioning and clinical examination with a goniometer and examines both elbow, knee and ankle joints using a goniometer for range of motion and axial alignment (0-3 points), pain numerical rating scale (0-10 points), swelling (0-3 points), crepitation (0-2 points) and gait abnormalities (0-4 points). A "total score" of 0 to 124 points is achievable. A higher score means a worse joint status.
Time frame
preoperative (approx. 1Day)2
Hip examination (Harris Hip Score)
The Harris Hip Score is is a combined test of questioning and clinical examination with a goniometer to assess hip complaints. The perceived pain, the function of the joint, existing deformities and the range of motion are assessed or queried with a total score of 0-100 points, with a low score indicating a functionally poorer hip joint.
Time frame
preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative3
Knee examination (Knee Society Score)
The Knee Society Score is a combined test of questioning and clinical examination with a goniometer and evaluates the functional ability of the knee joint after total or partial knee arthroplasty. This includes objective (knee alignment, knee instability, range of motion), functional (standard and advanced activities) and subjective (patient expectations and satisfaction, symptoms) components. A total of 0-100 points can be achieved, with a lower value signaling a poorer assessment of the knee joint.
Time frame
preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperative4
Blood samples
The blood samples of all patients are collected in the clinical routine in preparation for surgery and during the inpatient stay. As part of the study, the parameters vitamin D3 (nmol/l), calcium (nmol/l), creatine kinase (U/l), TSH (µu/ml), C-reactive protein (mg/l), leukocytes (G/l), hemoglobin (%) are used for statistical analyses.
Time frame
preoperative (approx. 1Day), postoperative (approx. 7 Days), 6-8 weeks postoperativeSponsors and contacts
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Source ClinicalTrials.gov