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Results of the Treatment of Patients With Elbow Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02951403
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Central Finland Hospital District
Information provided by (Responsible Party):
Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Elbow Osteoarthritis Procedure: Elbow arthroscopy Other: Conservative treatment Not Applicable

Detailed Description:
Patients will be recruited at departments of hand surgery and orthopedic surgery outpatient clinics. The control group will be patients to whom the conservative treatment continues. Patients who meet the inclusion criteria will be asked to participate and sign the informed consent. Therefore the investigators have two treatment groups: group 1 who receives an elbow joint debridement arthroscopically without physiotherapy and group 2 who receives only conservative treatment with physiotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Results of the Treatment of Patients With Elbow Osteoarthritis
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Operative treatment
Patients to whom the elbow arthroscopy will be performed.
Procedure: Elbow arthroscopy
Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.

Conservative treatment
Patients to whom special physiotherapy will be advised.
Other: Conservative treatment
Physiotherapy protocol is introduced to patients.




Primary Outcome Measures :
  1. Quick DASH score [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. VAS score [ Time Frame: 24 Months ]
  2. Range of motion [ Time Frame: 24 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951403


Contacts
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Contact: Margit Karelson, MD +358 3 311 66071 margit.karelson@pshp.fi
Contact: Antti Launonen, MD, PhD +358 3 311 69595 antti.launonen@pshp.fi

Locations
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Finland
Central Finland Central Hospital Not yet recruiting
Jyväskylä, Finland, 40620
Contact: Toni Luokkala, MD    +35814 2691811    toni.luokkala@ksshp.fi   
Tampere University Hospital Recruiting
Tampere, Finland, 33230
Contact: Margit Karelson, MD    +358 3 311 66071    margit.karelson@gmail.com   
Principal Investigator: Margit Karelson, MD         
Sub-Investigator: Antti Launonen, MD, PhD         
Sub-Investigator: Janne Lehtinen, MD, PhD         
Tampere University Hospital, Hatanpää Recruiting
Tampere, Finland, 33900
Contact: Janne Lehtinen, MD, PhD    +358 3 565713    janne.lehtinen@tampere.fi   
Sponsors and Collaborators
Tampere University Hospital
Central Finland Hospital District
Investigators
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Study Chair: Ville Mattila, MD, PhD professor
Principal Investigator: Margit Karelson, MD hand surgeon

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02951403     History of Changes
Other Study ID Numbers: R15117
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tampere University Hospital:
elbow arthroscopy
DASH
elbow locking
elbow osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases