Results of the Treatment of Patients With Elbow Osteoarthritis

NCT ID: NCT02951403

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elbow Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative treatment

Patients to whom the elbow arthroscopy will be performed.

Group Type EXPERIMENTAL

Elbow arthroscopy

Intervention Type PROCEDURE

Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.

Conservative treatment

Patients to whom special physiotherapy will be advised.

Group Type OTHER

Conservative treatment

Intervention Type OTHER

Physiotherapy protocol is introduced to patients.

Interventions

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Elbow arthroscopy

Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.

Intervention Type PROCEDURE

Conservative treatment

Physiotherapy protocol is introduced to patients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ville Mattila, MD, PhD

Role: STUDY_CHAIR

professor

Margit Karelson, MD

Role: PRINCIPAL_INVESTIGATOR

hand surgeon

Locations

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Central Finland Central Hospital

Jyväskylä, , Finland

Site Status NOT_YET_RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Tampere University Hospital, Hatanpää

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Margit Karelson, MD

Role: CONTACT

+358 3 311 66071

Antti Launonen, MD, PhD

Role: CONTACT

+358 3 311 69595

Facility Contacts

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Toni Luokkala, MD

Role: primary

+35814 2691811

Margit Karelson, MD

Role: primary

+358 3 311 66071

Janne Lehtinen, MD, PhD

Role: primary

+358 3 565713

Other Identifiers

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R15117

Identifier Type: -

Identifier Source: org_study_id

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