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Pyrocarbon Interposition Arthroplasty of the Elbow

NCT05464459 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-08-17

No results posted yet for this study

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

Conditions

  • Osteoarthritis of Elbow

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.

Sponsors & Collaborators

  • Edge Hill University

    collaborator OTHER

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Adam Watts · Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464459 on ClinicalTrials.gov