Clinical trial NCT03809962: Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
Official title: Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coxarthrosis
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.

Brief summary: PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.


Eligibility criteria: Inclusion Criteria:

1. Subjects ≥ 18 years of age and in good general health condition
2. Signed informed consent
3. Existing Ostenil® Plus recommendation for the treatment of coxarthrosis

Exclusion Criteria:

1. Known hypersensitivity to one of the OSTENIL® PLUS components
2. Known pregnancy or lactating females
3. Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
4. Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
5. Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)

Primary outcomes:
measure: Change of Pain Intensity compared to Baseline (VAS-slider)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Range of Motion compared to Baseline (Goniometer measurement)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to Day 252 after the last injection
measure: Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline
timeFrame: Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline
timeFrame: Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline
timeFrame: Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline
timeFrame: Day 84 after last injection, Day 168 after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oldesloe
country: Germany
facility: Gemeinschaftspraxis für Orthopädie und Unfallchirurgie
state: Schleswig-Holstein
city: Gettorf
country: Germany
facility: Orthopraxis Kiel
state: Schleswig-Holstein
city: Heide
country: Germany
facility: Zentrum für Medizin des Bewegungsapparates
state: Schleswig-Holstein
city: Eutin
country: Germany
facility: Orthopädische Gemeinschaftspraxis Eutin
city: Hamburg
country: Germany
facility: Orthopädische Praxis Rahlstedt
city: Ramelsloh
country: Germany
facility: Orthopädie Praxis
city: Seevetal
country: Germany
facility: OrthopädieZentrum Maschen
Study officials:
affiliation: OrthopädieZentrum Maschen
name: Knut Behle, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopädie Praxis Dr. Darja Becker
name: Darja Becker, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: