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Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03887234
Enrollment
27
Registered
2019-03-22
Start date
2018-09-01
Completion date
2022-10-19
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AC Joint Dislocation

Brief 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.

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.

Interventions

PROCEDURECoracoclavicular ligament reconstruction

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Either the two operation methods is chosen by opening a sealed envelope.

Intervention model description

Prospective randomized follow-up study. Two groups.

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion criteria

Severe new trauma after the treatment

Design outcomes

Primary

MeasureTime frameDescription
Total number of wound infections in the clavicular describing the safety of the used implanttwo monthsClinical sign questionnaire, scale 0-1 (no-yes)

Secondary

MeasureTime frameDescription
Constant score, scale 0-100, 100 denoting excellentScore is taken postoperatively and after two years follow-upGeneral shoulder test; describes the general state of the shoulder
Simple shoulder test, scale 0-12, 12 denoting excellentScore is taken postoperatively and after two years follow-upGeneral shoulder test; describes the general state of the shoulder
Nottingham clavicle score, scale 20-100, 100 denoting excellentScore is taken postoperatively and after two years follow-upAC joint specific test; describes the state of the AC joint and clavicle
Clavicular tunnel diameterThe measure is taken postoperatively and after two years follow-upDescribes possible adverse expansion of the tunnel; millimeters
Coracoclavicular distanceThe measure is taken postoperatively and after two years follow-upDescribes possible adverse increase of the coracoclavicular distance; millimeters

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026