Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis

NCT03809962 | Completed

• 1 other identifier: OSTH-PMCF-DE-2018-01
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 7

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.

Conditions

Coxarthrosis

Outcome Measures

Primary Outcomes (8)

• Change of Pain Intensity compared to Baseline (VAS-slider)

  Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider (10 cm equals the most pain)

  Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

• Change of Range of Motion compared to Baseline (Goniometer measurement)

  Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.

  Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

• Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)

  The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).

  Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

• Incidence of Treatment-Emergent Adverse Events

  Up to Day 252 after the last injection

• Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline

  Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale

  Day 84 after last injection, Day 168 after last injection

• Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline

  Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale

  Day 84 after last injection, Day 168 after last injection

• Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline

  Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale

  Day 84 after last injection, Day 168 after last injection

• Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline

  Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale

  Day 84 after last injection, Day 168 after last injection

Study Arms (1)

Ostenil® Plus

1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.

Device: Ostenil® Plus

Interventions

Ostenil® Plus DEVICE

Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation

Ostenil® Plus

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.

You may qualify if:

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

You may not qualify if:

• Known hypersensitivity to one of the OSTENIL® PLUS components
• Known pregnancy or lactating females
• 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
• 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)

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (7)

Orthopädische Praxis Rahlstedt

Hamburg, Hamburg, 22143, Germany

Location

Gemeinschaftspraxis für Orthopädie und Unfallchirurgie

Bad Oldesloe, Schleswig-Holstein, 23843, Germany

Location

Orthopraxis Kiel

Gettorf, Schleswig-Holstein, 24214, Germany

Location

Zentrum für Medizin des Bewegungsapparates

Heide, Schleswig-Holstein, 25746, Germany

Location

Orthopädische Gemeinschaftspraxis Eutin

Eutin, 23701, Germany

Location

Orthopädie Praxis

Ramelsloh, 21220, Germany

Location

OrthopädieZentrum Maschen

Seevetal, 21220, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Knut Behle, Dr. med.

  OrthopädieZentrum Maschen

  PRINCIPAL INVESTIGATOR

• Darja Becker, Dr. med.

  Orthopädie Praxis Dr. Darja Becker

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: February 15, 2019
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

DE (7)