RecruitingACTRN12606000196549

The efficacy of two alternative suture anchors, Panalok and bioraptor 2.3 for primary stabilisation of the shoulder for instability and identification of risk factors for recurrence of the shoulder instability post operation

The efficacy of 2 alternative suture materials Ethibond and Panacryl used with Panalok 'suture anchors' for the primary open surgical stabilisation of the shoulder for instability - a double blind randomised trial

Sponsor

Simon BELL

Enrollment

236 participants

Start Date

May 30, 2006

Study Type

Interventional

Conditions

Shoulder stabilisation: shoulder instability episodes not controlled with conservative measures

Summary

During stabilisation of the shoulder which has been unstable (dislocated) the surgeon attaches back the damaged ligament to the bone with a 'Panalok" suture anchor. This is tied into place with a separate suture made of either panacryl which dissolves or ethibond which does not. The hypothesis is that there is no differenvce between the sutures but the bioabsorbable (dissolving) suture theoretically should be preferred because is disolves away completed and reduces the risk of foreign body reactions. The sutures are dyed the same colour so the surgeon, the patient , the ward staff and outcome assessors are blinded

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of stitching material (sutures) used during shoulder stabilisation surgery to fix a dislocated or repeatedly unstable shoulder. One type of suture dissolves over time (bioabsorbable), and the other does not. Researchers want to know if there is a difference in how well the shoulder stays stable after surgery and whether there are any problems with either type of suture. You may be eligible if: - You are between 16 and 45 years old - You need surgery to stabilise an unstable (dislocating) shoulder - You have given informed consent You may NOT be eligible if: - You have already had a previous shoulder stabilisation surgery on the same shoulder Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Use of Panalok suture anchors with either a bioabsorbable suture (panacryl) or non- absorbable suture (ethibond) used during open surgical stabilisation of the shoulder for instability.

Locations(1)

VIC, Australia

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ACTRN12606000196549