Results of the Treatment of Patients With Elbow Osteoarthritis

Elbow Osteoarthritis Clinical Trial

Official title:

Results of the Treatment of Patients With Elbow Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02951403
• Other study ID #: R15117
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Tampere University Hospital
• Contact: Margit Karelson, MD
• Phone: +358 3 311 66071
• Email: margit.karelson[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Elbow Osteoarthritis
• Osteoarthritis

Intervention

Procedure:
• Elbow arthroscopy
Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.

Other:
• Conservative treatment
Physiotherapy protocol is introduced to patients.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Tampere University Hospital	Tampere
Finland	Tampere University Hospital, Hatanpää	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick DASH score		24 Months
Secondary	VAS score		24 Months
Secondary	Range of motion		24 Months