Elbow OsteoarthritisNCT02951403
Results of the Treatment of Patients With Elbow Osteoarthritis
A study testing Elbow arthroscopy and Conservative treatment in people with Elbow Osteoarthritis, run by Tampere University Hospital at 3 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elbow Osteoarthritis
- What is being tested?
- Elbow arthroscopy and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFinland
- Study dates
- Jan 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites, 3 recruiting
- Not yet recruiting
Central Finland Central Hospital
Jyväskylä, 40620
Toni Luokkala, MD, +35814 2691811, toni.luokkala@ksshp.fi
- Recruiting
Tampere University Hospital
Tampere, 33230
Margit Karelson, MD, +358 3 311 66071, margit.karelson@gmail.com
Margit Karelson, MD
- Recruiting
Tampere University Hospital, Hatanpää
Tampere, 33900
Janne Lehtinen, MD, PhD, +358 3 565713, janne.lehtinen@tampere.fi
About this study
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.
Read the 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.
- Conditions
- Elbow Osteoarthritis
- Being tested
- Elbow arthroscopy, Conservative treatment
- Keywords
- elbow arthroscopy, DASH, elbow locking, elbow osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow arthroscopyProcedure or surgery
Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.
Conservative treatmentOther
Physiotherapy protocol is introduced to patients.
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Experimental | Patients to whom the elbow arthroscopy will be performed. Receives: Procedure: Elbow arthroscopy |
| Conservative treatment | Other | Patients to whom special physiotherapy will be advised. Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick DASH score
Measured: 24 Months
Secondary outcomes (2)
VAS score
Measured: 24 Months
Range of motion
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District
- Responsible party
- Sponsor
- Investigators
- Ville Mattila, MD, PhD, Study chair, professorMargit Karelson, MD, Principal investigator, hand surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951403
- Sponsor's protocol ID
- R15117
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Treatment of Patients With Elbow Osteoarthritis
- ClinicalTrials.gov ID
- NCT02951403
- Acronym / sponsor ID
- R15117
- Conditions
- Elbow Osteoarthritis
- Keywords
- elbow arthroscopy, DASH, elbow locking, elbow osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Experimental | Procedure: Elbow arthroscopyPatients to whom the elbow arthroscopy will be performed. |
| Conservative treatment | Other | Other: Conservative treatmentPatients to whom special physiotherapy will be advised. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbow arthroscopyArthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients. | Procedure or surgery | Operative treatment |
| Conservative treatmentPhysiotherapy protocol is introduced to patients. | Other | Conservative treatment |
Primary outcome
Quick DASH score
Time frame: 24 Months
2 secondary outcomes
VAS score
Time frame: 24 Months
Range of motion
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ville Mattila, MD, PhD study chair
professor
Margit Karelson, MD principal investigator
hand surgeon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow arthroscopy and Conservative treatment in people with Elbow Osteoarthritis, run by Tampere University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margit Karelson, MD (+358 3 311 66071, margit.karelson@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick DASH score (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.