Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction

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• Joint Dislocations 98

Keywords

• anatomic ligament reconstruction
• acromioclavicular disjunction

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 37 observational studies indexed under Joint Dislocations.

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.

Study population

Primary outcomes

1. Acromioclavicular reduction

   The parameters measured and compared with the contralateral side will be : * The CC (coracoclavicular) distance measured on the anteroposterior Zanca view * The AC-DC distance(Acromial center line to dorsal clavicle) * The GC-PC distance (Glenoid center line to posterior clavicle) Assessment of the result of the intervention on the acromioclavicular radiological reduction 3 months post-operatively according to the quantitative radiographic parameters described by Zumstein. The reduction will be considered as: * Complete if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin of less than 10%. * Partial if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin between 10% and 20%. * Poor if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin greater than 20%.

   Time frame: Month 3

Secondary outcomes

1. Pain assessement

   Progression of pain with the Self-Constant score. Self-Constant score explores several domains such as pain, activity, strength, and mobility(functional evaluation) : * Pain is assessed using a numerical scale ranging from 0 (no pain) to 10 (unbearable pain) * Professional and leisure activities are evaluated by the patient using a numerical scale ranging from 0 (no activities possible) to 10 (all activities possible) * Mobility: the ranges to be considered are those that are possible actively and without pain. Active anterior elevation, active abduction, and active external rotation are evaluated by the patient with reference to photographs showing the different levels of range of motion * Muscle strength is evaluated according to the patient's ability to lift a certain number of common objects (from a 500 g can to a 9 kg pack of water) The total score ranges from 0 to 100 points, with 100 indicating a normal shoulder and 0 indicating a completely deficient shoulder

   Time frame: Month 24

2. Shoulder functional assessment with the the ACJI Score (Acromioclavicular Joint Instability Score)

   Describe, over the 2 years following surgery, changes in shoulder function scores: The ACJI Score (Acromioclavicular Joint Instability Score) assesses acromioclavicular joint instability across five dimensions: * Spontaneous pain and pain on palpation (out of 20 points) * Activities of daily living (out of 10 points) * Aesthetics (out of 10 points) * Function (out of 25 points), including evaluation of range of motion (flexion, abduction, external rotation, internal rotation) and abduction strength at 90° abduction * Radiological findings (out of 35 points): post-traumatic osteoarthritis, vertical stability, and horizontal stability The final score ranges from 0 to 100, with 0 corresponding to almost no function and 100 to normal function.

   Time frame: Month 3

3. Return to work

   Time to return to work after discharge from hospital

   Time frame: Month 24

4. Resumption of physical and sporting activities (with the Self-Constant score)

   Describe, over the 2 years following the intervention, the time and level of resumption of physical and sporting activities with Self-Constant score ranges from 0 (deficient shoulder) to 100 (normal shouder). Self-Constant score explores several domains such as pain, activity, strength, and mobility (functional evaluation): * Pain is assessed using a numerical scale ranging from 0 (no pain) to 10 (unbearable pain) * Professional and leisure activities are evaluated by the patient using a numerical scale ranging from 0 (no activities possible) to 10 (all activities possible) * Mobility: the ranges to be considered are those that are possible actively and without pain. Active anterior elevation, active abduction, and active external rotation are evaluated by the patient with reference to photographs showing the different levels of range of motion * Muscle strength is evaluated according to the patient's ability to lift a certain number of common objects (from 500g can to 9kg pack of water)

   Time frame: Month 24

5. Patient satisfaction

   Overall Assessment of Patient Satisfaction : Patient satisfaction with their care and outcomes will be assessed at the end of the study on a simple numerical scale ranging from 0 (very dissatisfied) to 10 (very satisfied).

   Time frame: Month 24

6. Shoulder Functional assessment with the SSV Score (Subjective Shoulder Value Score)

   Describe, over the 2 years following surgery, changes in shoulder function scores : The SSV Score (Subjective Shoulder Value Score) is a subjective assessment score that allows the patient to evaluate the value of their affected shoulder compared to a completely healthy shoulder. The result is expressed as a percentage (between 0 % and 100%, 0 is an anormal function and 100% a normal function of the shoulder).

   Time frame: Month 24

7. Resumption of physical and sporting activities with the ACJI score

   Describe, over the 2 years following the intervention, the time and level of resumption of physical and sporting activities with the ACJI score (acromioclavicular joint instability score). The ACJI Score (Acromioclavicular Joint Instability Score) assesses acromioclavicular joint instability across five dimensions: * Spontaneous pain and pain on palpation (out of 20 points) * Activities of daily living (out of 10 points) * Aesthetics (out of 10 points) * Function (out of 25 points), including evaluation of range of motion (flexion, abduction, external rotation, internal rotation) and abduction strength at 90° abduction * Radiological findings (out of 35 points): post-traumatic osteoarthritis, vertical stability, and horizontal stability The final score ranges from 0 to 100, with 0 corresponding to almost no function and 100 to normal function.

   Time frame: Month 3