Results of the Treatment of Patients With Elbow Osteoarthritis
1 other identifier
interventional
100
1 country
3
Brief Summary
The study is a prospective case controlled clinical trial. The purpose of the study is to investigate the effect of elbow arthroscopy in the treatment for osteoarthritis of the elbow when compared to conservative treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 17, 2019
September 1, 2019
4.9 years
June 6, 2016
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quick DASH score
24 Months
Secondary Outcomes (2)
VAS score
24 Months
Range of motion
24 Months
Study Arms (2)
Operative treatment
EXPERIMENTALPatients to whom the elbow arthroscopy will be performed.
Conservative treatment
OTHERPatients to whom special physiotherapy will be advised.
Interventions
Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.
Eligibility Criteria
You may qualify if:
- Symptomatic post-traumatic or primary osteoarthritis - mechanical locking and/or decreased range of motion ( \>30°)
- Radiographic evidence of at least mild primary or post-traumatic osteoarthritis according to Broberg - Morrey classification symptoms lasting at least 6 months
- Patients willingness to participate the study
- All patients 18-80 ages
You may not qualify if:
- Patients with previous severe soft tissue trauma at elbow region ( crush, burns etc - the elbow joint problems are not joint specific)
- Patients with crystal arthropathy or inflammatory arthritis
- Patient refuses to participate the study
- Patients with dementia or are institutionalized
- Patients with severe substance addiction
- Patient does not understand written and spoken guidance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Central Finland Hospital Districtcollaborator
Study Sites (3)
Central Finland Central Hospital
Jyväskylä, 40620, Finland
Tampere University Hospital
Tampere, 33230, Finland
Tampere University Hospital, Hatanpää
Tampere, 33900, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ville Mattila, MD, PhD
professor
- PRINCIPAL INVESTIGATOR
Margit Karelson, MD
hand surgeon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
November 1, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
September 17, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share