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Clinical Trials/NCT02951403
NCT02951403UnknownNot Applicable

Results of the Treatment of Patients With Elbow Osteoarthritis

Tampere University Hospital6 sites in 1 country100 target enrollmentStarted: January 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
6
Primary Endpoint
Quick DASH score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Operative treatment

Experimental

Patients to whom the elbow arthroscopy will be performed.

Intervention: Elbow arthroscopy (Procedure)

Conservative treatment

Other

Patients to whom special physiotherapy will be advised.

Intervention: Conservative treatment (Other)

Outcomes

Primary Outcomes

Quick DASH score

Time Frame: 24 Months

Secondary Outcomes

  • Range of motion(24 Months)
  • VAS score(24 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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