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Results of the Treatment of Patients With Elbow Osteoarthritis

Primary Purpose

Elbow Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Elbow arthroscopy

Conservative treatment

About this trial

This is an interventional treatment trial for Elbow Osteoarthritis focused on measuring elbow arthroscopy, DASH, elbow locking, elbow osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Central Finland Central Hospital
Tampere University HospitalRecruiting
Tampere University Hospital, HatanpääRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Operative treatment

Conservative treatment

Arm Description

Patients to whom the elbow arthroscopy will be performed.

Patients to whom special physiotherapy will be advised.

Outcomes

Primary Outcome Measures

Quick DASH score

Secondary Outcome Measures

VAS score

Range of motion

Full Information

NCT ID

NCT02951403

First Posted

June 6, 2016

Last Updated

September 16, 2019

Sponsor

Tampere University Hospital

Collaborators

Central Finland Hospital District

1. Study Identification

Unique Protocol Identification Number

NCT02951403

Brief Title

Results of the Treatment of Patients With Elbow Osteoarthritis

Official Title

Results of the Treatment of Patients With Elbow Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tampere University Hospital

Collaborators

Central Finland Hospital District

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Elbow Osteoarthritis

Keywords

elbow arthroscopy, DASH, elbow locking, elbow osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Operative treatment

Arm Type

Experimental

Arm Description

Patients to whom the elbow arthroscopy will be performed.

Arm Title

Conservative treatment

Arm Type

Other

Arm Description

Patients to whom special physiotherapy will be advised.

Intervention Type

Procedure

Intervention Name(s)

Elbow arthroscopy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conservative treatment

Intervention Description

Physiotherapy protocol is introduced to patients.

Primary Outcome Measure Information:

Title

Quick DASH score

Time Frame

24 Months

Secondary Outcome Measure Information:

Title

VAS score

Time Frame

24 Months

Title

Range of motion

Time Frame

24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Margit Karelson, MD

Phone

+358 3 311 66071

margit.karelson@pshp.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Antti Launonen, MD, PhD

Phone

+358 3 311 69595

antti.launonen@pshp.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ville Mattila, MD, PhD

Organizational Affiliation

professor

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Margit Karelson, MD

Organizational Affiliation

hand surgeon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Finland Central Hospital

City

Jyväskylä

ZIP/Postal Code

40620

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Toni Luokkala, MD

Phone

+35814 2691811

toni.luokkala@ksshp.fi

Facility Name

Tampere University Hospital

City

Tampere

ZIP/Postal Code

33230

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margit Karelson, MD

Phone

+358 3 311 66071

margit.karelson@gmail.com

First Name & Middle Initial & Last Name & Degree

Margit Karelson, MD

First Name & Middle Initial & Last Name & Degree

Antti Launonen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Janne Lehtinen, MD, PhD

Facility Name

Tampere University Hospital, Hatanpää

City

Tampere

ZIP/Postal Code

33900

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janne Lehtinen, MD, PhD

Phone

+358 3 565713

janne.lehtinen@tampere.fi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Results of the Treatment of Patients With Elbow Osteoarthritis

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