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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000196549

Acronym

Anchor stabilisation study

Enrollment

236

Registered

2006-05-26

Start date

2006-05-30

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 45 Years

Healthy volunteers

Inclusion criteria

Informed consent. Requiring anterior shoulder stabilisation.

Exclusion criteria

Previous stabilisation surgery to this shoulder.

Outcome results