Primary Osteoarthritis, ElbowNCT05184010
Arthroscopic Treatment With Ulnar Nerve Release for Elbow Osteoarthritis
A study testing ulnar nerve mini open release and without ulnar nerve mini open release in people with Primary Osteoarthritis, Elbow and Ulnar Nerve Release, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Elbow, Ulnar Nerve Release
- What is being tested?
- ulnar nerve mini open release and without ulnar nerve mini open release
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 30 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement.
- Ulnar neuropathy proven by electromyography without clinical symptoms
- Failure at least 6 months of conservative treatment
- Availability of medical information for >2 years of follow-up
Who cannot join
- Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery.
- Revision surgery
- Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency
- Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness.
- Inadequate or loss of follow-up
- elbow instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial
This study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. Before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). In different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.
- Conditions
- Primary Osteoarthritis, Elbow, Ulnar Nerve Release
- Being tested
- ulnar nerve mini open release, without ulnar nerve mini open release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulnar nerve mini open releaseDevice
the ulnar nerve mini open release was performed before arthroscopic release for elbow
without ulnar nerve mini open releaseDevice
arthroscopic release for elbow stiffness alone without ulnar nerve mini open release
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic release with ulnar nerve mini open release | Experimental | Not described Receives: Device: ulnar nerve mini open release |
| arthroscopic release alone without ulnar nerve mini open release | Placebo comparator | Not described Receives: Device: without ulnar nerve mini open release |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome
Measured: baseline-2 years postoperatively
Secondary outcomes (3)
ROM(F-E and rotation)
the motion of the elbow
Measured: baseline-2 years postoperatively
Strength
the strength test contain flex and extend the elbow, made a comparison with contralateral elbow.
Measured: baseline-2 years postoperatively
MEPS
A score used to evaluated the elbow function
Measured: baseline-2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start30 Jan 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis, ElbowStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
- Investigators
- Yi Lu, Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184010
- Sponsor's protocol ID
- Yi Lu
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment With and Without Ulnar Nerve Release for Elbow Osteoarthritis --a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05184010
- Acronym / sponsor ID
- Yi Lu
- Conditions
- Primary Osteoarthritis, Elbow, Ulnar Nerve Release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- 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.
This study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. The patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. Before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). In different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthroscopic release with ulnar nerve mini open release | Experimental | Device: ulnar nerve mini open release |
| arthroscopic release alone without ulnar nerve mini open release | Placebo comparator | Device: without ulnar nerve mini open release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Primary osteoarthritis of the elbow with stiffness. Osteoarthritis was confirmed on CT-arthrography, by cartilage damage, osteophytes or local or global joint impingement.
- Ulnar neuropathy proven by electromyography without clinical symptoms
- Failure at least 6 months of conservative treatment
- Availability of medical information for >2 years of follow-up
Key exclusion criteria (6 listed)
- Severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery.
- Revision surgery
- Ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency
- Other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness.
- Inadequate or loss of follow-up
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 |
|---|---|---|
| ulnar nerve mini open releasethe ulnar nerve mini open release was performed before arthroscopic release for elbow | Device | arthroscopic release with ulnar nerve mini open release |
| without ulnar nerve mini open releasearthroscopic release for elbow stiffness alone without ulnar nerve mini open release | Device | arthroscopic release alone without ulnar nerve mini open release |
Primary outcome
DASH
Time frame: baseline-2 years postoperatively
A score used to evaluated the elbow function,range of 0-100, 100 means worst outcome
3 secondary outcomes
ROM(F-E and rotation)
Time frame: baseline-2 years postoperatively
Strength
Time frame: baseline-2 years postoperatively
MEPS
Time frame: baseline-2 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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.
Yi Lu principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ulnar nerve mini open release and without ulnar nerve mini open release in people with Primary Osteoarthritis, Elbow and Ulnar Nerve Release, run by Beijing Jishuitan Hospital at 1 site in China.
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 5 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 Shangzhe Li, M.D. (+86 13826162999, 562744381@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (time frame: baseline-2 years postoperatively). 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 11 Jan 2022.