NCT03540667

Brief Summary

This multi-site, observational, prospective study aims to investigate current practice and associated outcomes for patients scheduled for elective unilateral total hip or knee arthroplasty in South Africa.This information will provide baseline values, against which effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients will be compared (the subsequent study).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

May 4, 2018

Last Update Submit

August 17, 2020

Conditions

Osteoarthritis, KneeOsteoarthritis, HipArthritis, RheumatoidArthritis KneeArthritis of Hip

Keywords

Total hip arthroplastyTotal knee arthroplastyTotal joint arthroplastyLow middle income countryEnhanced recovery pathway

Outcome Measures

Primary Outcomes (1)

  • "Days alive and at home 30 days after surgery" (DAH30)

    A patient centered measure which integrates length of hospital stay, readmission due to postoperative complications, discharge destination and early death after surgery . This outcome is an overall measure of the recovery profile as it captures much of the surgical experience, integrating efficacy, quality and safety thus reflecting value based care and actions. As such, DAH30 is transparent and can be used for benchmarking performance of quality of perioperative care.

    30 days

Secondary Outcomes (7)

  • Timed Up and Go test

    2-5 days after surgery

  • EQ-5D

    30 days and 1 year after surgery

  • EQ-VAS

    30 days and 1 year after surgery

  • Satisfaction with surgery

    30 days and 1 year after surgery

  • 1-year incidence of mortality

    1 year follow up

  • +2 more secondary outcomes

Study Arms (1)

Single group study

The study population will include patients presenting for primary elective unilateral total hip and knee arthroplasty.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for primary elective unilateral total hip or knee arthroplasty.

You may qualify if:

  • All patients scheduled for primary elective unilateral total hip or knee arthroplasty in the 10 week study period at the 10 participating study sites in South Africa.
  • Patients must accept to be contacted telephonically 30 days and 12 months after surgery.

You may not qualify if:

  • Patients who do not have a mobile telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitas Academic Hospital

Bloemfontein, Free State, 9300, South Africa

Location

Steve Biko Academic Hospital

Pretoria, Gauteng, 0001, South Africa

Location

Albert Luthuli Central Hospital

Durban, KwaZulu-Natal, 4058, South Africa

Location

Grey's Hospital

Pietermaritzburg, KwaZulu-Natal, 3200, South Africa

Location

Mitchells Plain Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Somerset Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Victoria Hospital

Cape Town, Western Cape, 7599, South Africa

Location

Groote Schuur Hospital

Cape Town, Western Cape, 7700, South Africa

Location

Paarl Hospital

Paarl, Western Cape, 7599, South Africa

Location

Related Publications (1)

  • Plenge U, Parker R, Davids S, Davies GL, Fullerton Z, Gray L, Groenewald P, Isaacs R, Kauta N, Louw FM, Mazibuko A, North DM, Nortje M, Nunes GM, Pebane N, Rajah C, Roos J, Ryan P, September WV, Shanahan H, Siebritz RE, Smit RW, Sombili S, Torborg A, van der Merwe JF, van der Westhuizen N, Biccard B. Quality of recovery after total hip and knee arthroplasty in South Africa: a national prospective observational cohort study. BMC Musculoskelet Disord. 2020 Nov 5;21(1):721. doi: 10.1186/s12891-020-03752-x.

    PMID: 33153453DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ulla Plenge, MD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Researcher

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 30, 2018

Study Start

May 7, 2018

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ZA(9)