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The effect of custom-made 3-D printed guides in total shoulder joint replacement

The effect of custom-made 3-D printed guides for insertion of the glenoid part in total shoulder arthroplasty. A prospective randomized study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12413814
Enrollment
118
Registered
2020-10-28
Start date
2021-06-14
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Shoulder osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

The participants will be randomly put into two groups (block randomization with four subjects in each block using STATA 16 MP): The intervention group will have 3D printed custom-made

Sponsors

University of Southern Denmark
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Shoulder osteoarthritis patients that will receive a shoulder arthroplasty

Exclusion criteria

Exclusion criteria: 1. Hypoplasia 2. Severe osteoarthritis requiring a custom made guide under all circumstances

Design outcomes

Primary

MeasureTime frame
1. Self-reported shoulder function measured using The Western Ontario Osteoarthritis of the Shoulder index at baseline, 3, 6, 12 and 24 months follow-up 2. Level of activity measured using the Constant-Murley score (by a physiotherapist) at baseline, 3, 6, 12 and 24 months follow-up 3. Self-reported pain level using numeric rating scale reported weekly by SMS

Secondary

MeasureTime frame
Placement of the arthroplasty assessed using a CT-scan at 12 months

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026