NCT03879434

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

5.1 years

First QC Date

March 15, 2019

Last Update Submit

October 8, 2024

Conditions

Rhizarthrosis

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 equal the worst pain)

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

  • Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline

    Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale

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

  • Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline

    Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale

    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 Key Pinch Strength compared to Baseline (Pinch Gauge)

    Measurement of Key Pinch in kilograms with a Pinch Gauge

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

  • Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)

    Measurement of Tip Pinch in kilograms with a Pinch Gauge

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

  • Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)

    Measurement of Palmar Pinch in kilograms with a Pinch Gauge

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

Study Arms (1)

Ostenil® Mini

1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval.

Device: Ostenil® Mini

Interventions

Ostenil® MiniDEVICE

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

Ostenil® Mini

Eligibility Criteria

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

Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity to one of the Ostenil® Mini components
  • Known pregnancy or lactating females
  • Presence of coagulation disorder
  • 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)

Orthopädie am Tauentzien

Berlin, State of Berlin, 10789, Germany

Location

Praxis für Orthopädie und Unfallchirurgie

Berlin, 10711, Germany

Location

MVZ Berlin Freiheit 1

Berlin, 12555, Germany

Location

Orthopädie am Kiesteich

Berlin, 13589, Germany

Location

Wirbelsäulen Gelenk Zentrum Westend

Berlin, 14052, Germany

Location

Orthopädie Wannsee

Berlin, 14109, Germany

Location

Study Design

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

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

April 17, 2019

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

DE(6)