AC Joint DislocationNCT03887234
Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques
A study testing Coracoclavicular ligament reconstruction in people with AC Joint Dislocation, run by University of Turku at 1 site in Finland.
Trial summary
This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- AC Joint Dislocation
- What is being tested?
- Coracoclavicular ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2018to 19 Oct 2022
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic acromioclavicular luxation
Who cannot join
- Severe new trauma after the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques
This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.
Read the detailed description
A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.
The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.
- Conditions
- AC Joint Dislocation
- Being tested
- Coracoclavicular ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coracoclavicular ligament reconstructionProcedure or surgery
Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation
| Study group | Role | What they receive |
|---|---|---|
| Through the coracoid | Active comparator | The semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole. Receives: Procedure: Coracoclavicular ligament reconstruction |
| Around the coracoid | Experimental | The semitendinosus tendon graft goes around the coracoid. Receives: Procedure: Coracoclavicular ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of wound infections in the clavicular describing the safety of the used implant
Clinical sign questionnaire, scale 0-1 (no-yes)
Measured: two months
Secondary outcomes (5)
Constant score, scale 0-100, 100 denoting excellent
General shoulder test; describes the general state of the shoulder
Measured: Score is taken postoperatively and after two years follow-up
Simple shoulder test, scale 0-12, 12 denoting excellent
General shoulder test; describes the general state of the shoulder
Measured: Score is taken postoperatively and after two years follow-up
Nottingham clavicle score, scale 20-100, 100 denoting excellent
AC joint specific test; describes the state of the AC joint and clavicle
Measured: Score is taken postoperatively and after two years follow-up
Clavicular tunnel diameter
Describes possible adverse expansion of the tunnel; millimeters
Measured: The measure is taken postoperatively and after two years follow-up
Coracoclavicular distance
Describes possible adverse increase of the coracoclavicular distance; millimeters
Measured: The measure is taken postoperatively and after two years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Sep 2018
- Primary completion19 Oct 2020
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AC Joint DislocationStudies 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
- Model description
- Prospective randomized follow-up study. Two groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Juha Ranne, University of Turku
- Investigators
- Juha O Ranne, M.D., Ph.D., Principal investigator, University of Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887234
- Sponsor's protocol ID
- R18114
- Status last verified
- Dec 2022
- First submitted
- 21 Jan 2019
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques
- ClinicalTrials.gov ID
- NCT03887234
- Acronym / sponsor ID
- R18114
- Conditions
- AC Joint Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 22 Mar 2019 (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 follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.
Detailed description
A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.
The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective randomized follow-up study. Two groups.
| Arm | Type | Receives |
|---|---|---|
| Through the coracoid | Active comparator | Procedure: Coracoclavicular ligament reconstructionThe semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole. |
| Around the coracoid | Experimental | Procedure: Coracoclavicular ligament reconstructionThe semitendinosus tendon graft goes around the coracoid. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic acromioclavicular luxation
Key exclusion criteria (1 listed)
- Severe new trauma after the treatment
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 |
|---|---|---|
| Coracoclavicular ligament reconstructionArthroscopically conducted ligament reconstruction for the treatment of an AC dislocation | Procedure or surgery | Around the coracoid, Through the coracoid |
Primary outcome
Total number of wound infections in the clavicular describing the safety of the used implant
Time frame: two months
Clinical sign questionnaire, scale 0-1 (no-yes)
5 secondary outcomes
Constant score, scale 0-100, 100 denoting excellent
Time frame: Score is taken postoperatively and after two years follow-up
Simple shoulder test, scale 0-12, 12 denoting excellent
Time frame: Score is taken postoperatively and after two years follow-up
Nottingham clavicle score, scale 20-100, 100 denoting excellent
Time frame: Score is taken postoperatively and after two years follow-up
Clavicular tunnel diameter
Time frame: The measure is taken postoperatively and after two years follow-up
Coracoclavicular distance
Time frame: The measure is taken postoperatively and after two years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
Related trials for AC Joint Dislocation
Enrolling by invitation
Comparison of Single Tunnel Versus Double Tunnel Techniques for Coracoclavicular Stabilization in Acromioclavicular Joint Injuries
AC Joint Dislocation
Not yet recruiting
Acute ACJ Dislocation Type (III&VI): CC Ligaments Reconstruction With AC Ligament Reconstruction vs. CC Ligaments Reconstruction With AC Temporary k Wire Fixation
Acromioclavicular Joint, Acromioclavicular Joint Dislocation
Recruiting
Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury
Acromioclavicular Joint Dislocation
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.
Juha O Ranne, M.D., Ph.D. principal investigator
University of Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coracoclavicular ligament reconstruction in people with AC Joint Dislocation, run by University of Turku at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of wound infections in the clavicular describing the safety of the used implant (time frame: two 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 27 Dec 2022.