Pyrocarbon Interposition Arthroplasty of the Elbow

NCT05464459 | Active Not Recruiting

• 1 other identifier: HAPY
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and acceptability

  The principal research objective is to assess the safety and acceptability of interposition arthroplasty of the elbow using a spherical pyrocarbon implant in a prospective consecutive case series of carefully selected patients.

  24 months

Secondary Outcomes (1)

• Motion Analysis

  24 months

Study Arms (1)

HAPY interposition elbow replacement

EXPERIMENTAL

HAPY is a pyrocarbon sphere for use as an interposition joint replacement. In this study, the implant is being used as a novel procedure in the Elbow (outside approved label usage)

Procedure: Novel elbow procedure

Interventions

Novel elbow procedure 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.

HAPY interposition elbow replacement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Medically fit for surgery
• Advanced osteoarthritis, post-traumatic arthritis, or post-septic arthritis
• Severe inflammatory arthritis without severe bone destruction - Larsen grade III or less
• Failed conservative treatment
• Unsuitable for TEA due to high functional demands

You may not qualify if:

• Severe inflammatory arthritis with severe bone destruction
• Arthritis suitable for treatment with arthroscopic debridement.

Sponsors & Collaborators

• Wrightington, Wigan and Leigh NHS Foundation Trust: lead
• Edge Hill University: collaborator

Study Sites (1)

Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN6 9EP, United Kingdom

Location

Study Officials

• Adam Watts

  Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)