Results of the Treatment of Patients With Elbow Osteoarthritis

September 16, 2019 updated by: Tampere University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Not yet recruiting
        • Central Finland Central Hospital
        • Contact:
      • Tampere, Finland, 33230
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Principal Investigator:
          • Margit Karelson, MD
        • Sub-Investigator:
          • Antti Launonen, MD, PhD
        • Sub-Investigator:
          • Janne Lehtinen, MD, PhD
      • Tampere, Finland, 33900
        • Recruiting
        • Tampere University Hospital, Hatanpää
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quick DASH score
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS score
Time Frame: 24 Months
24 Months
Range of motion
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Central Finland Hospital District

Investigators

  • Study Chair: Ville Mattila, MD, PhD, Professor
  • Principal Investigator: Margit Karelson, MD, hand surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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