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ACTIVE NOT RECRUITING
NCT05464459
NA

Pyrocarbon Interposition Arthroplasty of the Elbow

Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust

View on ClinicalTrials.gov

Summary

The current study will be a prospective observational study (or collective case study in a small, carefully selected cohort of consenting patients with advanced arthritis. This study would be classified as a stage I study according the IDEAL framework for surgical innovation

Official title: A Prospective Case Series to Evaluate the Outcomes and Acceptability of a Novel Surgical Technique of Pyrocarbon Interposition Arthroplasty of the Elbow, in Young Patients With Severe Arthritis.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2022-10-17

Completion Date

2026-12-31

Last Updated

2025-08-17

Healthy Volunteers

Yes

Interventions

PROCEDURE

Novel elbow procedure

A general anaesthetic plus upper limb nerve block is used with no tourniquet. Antibiotics and tranexamic acid are administered intravenously prior to procedure. Skin prepared by standard technique with alcoholic chlorhexidine. A posterior midline incision is made and lateral paraolecranon approach made to the elbow joint. Lateral ligament complex released for access and repaired at the end of the procedure. A 5mm high speed burr and HAPY burr instrument prepares the distal humerus. The trochlea spool and/or capitellum are resected to receive Pyrocarbon spherical prosthesis, size determined from pre-operative planning. The greater sigmoid notch is prepared in a similar manner with burr. A trial prosthesis is used to assess joint movement/stability before the Pyrocarbon spherical spacer inserted. Wound closed in layers with heavy vicryl. Skin closure with subcutaneous monocryl. Physiotherapist advice within 24 hours and immediate active mobilisation is commenced as comfort allows.

Locations (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, United Kingdom