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Difference in early postoperative stiffness and pain after arthroscopic rotator cuff repair: bio-absorbable versus non-absorbable titanium and PEEK implants

Difference in early postoperative stiffness and pain after arthroscopic rotator cuff repair: bio-absorbable versus non-absorbable titanium and PEEK implants - Early stiffness cuffrepair: bio-absorbable vs 2 nonabsorbable implants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41562
Enrollment
90
Registered
2010-06-01
Start date
2010-10-06
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

lesion shoulder tendon lesion supraspinatus tendon

Interventions

Supraspinatus lesions were repaired using a standardized arthroscopic approach and a double row technique. Patients were randomized to receive commercially available absorbable (n=30), titanium (n=3

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Willing and able to participate in the study protocol - Age > 18 years - Diagnosed with a small to medium tear of the supraspinatus tendon, confirmed by ultra sound, symptoms persevering over 6 months despite conservative treatment including physiotherapy, possible subacromial infiltration with corticosteroids and anti inflammatory drugs.

Exclusion criteria

Exclusion criteria: - Unable to give informed concent - Language barrier - Frozen shoulder - Previous surgery to the shoulder or additional injury as in fractures - Increased surgical risk( ASA >3) - patients under 18 - diabetes mellitus

Design outcomes

Primary

MeasureTime frame
The difference between the three, previous described patient groups, with regard to: postoperative shoulder stiffness (ea. a 10* deficit in postoperative external rotation).

Secondary

MeasureTime frame
Postoperative outcome: functional (according to Oxford Shoulder Score and Range Of Motion), Tendon integrity (ultra sound).Postoperative pain (VAS). Patient satisfaction (very satisfied, satisfied, not satisfied, displeased). Total number of adverse reactions. Also record any side effects encountered. Cost-effectiveness of the three different types of anchors used.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)