NCT03734315

Brief Summary

PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

October 30, 2018

Last Update Submit

October 8, 2024

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (5)

  • 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 worst pain.

    Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252

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

    Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.

    Day 7, Day 14, Day 21, Day 28, Day 84, Day 168

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

    Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.

    Day 84, Day 168

  • 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 21, Day 28, Day 84, Day 168, Day 252

  • Incidence of Treatment-Emergent Adverse Events

    Up to Day 252

Study Arms (1)

Ostenil®

3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.

Device: Ostenil®

Interventions

Ostenil®DEVICE

Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.

Ostenil®

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity to one of the Ostenil® components
  • Presence of articular effusion in study-relevant knee joint
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Orthopädisches Versorgungszentrum München-Ost

Munich, Bavaria, 81825, Germany

Location

Orthopädie am Altheimer Eck

München, Bavaria, 80331, Germany

Location

Orthopädie München

München, Bavaria, 80331, Germany

Location

Orthopädische Praxis am Isartor

München, Bavaria, 80331, Germany

Location

MVZ am Nordbad

München, Bavaria, 80797, Germany

Location

Orthopädische Praxis

München, Bavaria, 80993, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Krüger-Franke, Dr. med.

    MVZ am Nordbad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 7, 2018

Study Start

January 8, 2019

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)