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Arthroplasty studies with greater than 1000 participants: analysis of follow-up methods.

ABSTRACT: Background:The use of patient-reported outcome measures (PROMs) has become a mainstay of orthopedic joint arthroplasty research. Large studies with >1000 participants are vital to orthopedic research, as they allow for comprehensive multivariable analysis. Achieving high follow-up rates minimizes potential response bias. Maintaining adequate follow-up rates becomes more challenging as sample size increases. We aimed to systematically review the present literature to determine the follow-up rates of large cohorts/registries of total joint arthroplasty patients and to identify factors associated with successful collection of PROMs. Methods:A comprehensive literature search of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria were: ≥1000 participants, ≥6 months of postoperative follow-up, and use of validated PROMs postoperatively. Results:Of 720 abstracts screened, 21 studies met inclusion criteria. Only 2 studies reported achieving a PROM follow-up rate ≥80%, but neither collected PROMs preoperatively. The median rate of follow-up was 70%, and the median number of patients was 2970. Only 38% (8 of 21) of studies collected baseline PROMs prior to surgery. Conclusions:Very few studies in the present literature have collected validated PROMs on ≥1000 patients with ≥80% follow-up; these parameters are conducive to comprehensive multivariable analysis, while maintaining study validity and avoiding follow-up bias. Federal funding and a central coordinating site may be helpful in achieving follow-up in studies of this magnitude. Level of Evidence:Level III, systematic review of studies with Level of Evidence I-III.

SUBMITTER: Tariq MB

PROVIDER: S-EPMC6588815 | biostudies-other | 2019 Jun

REPOSITORIES: biostudies-other

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Arthroplasty studies with greater than 1000 participants: analysis of follow-up methods.

Tariq Muhammad B MB Vega José F JF Westermann Robert R Jones Morgan M Spindler Kurt P KP

Arthroplasty today 20190507 2

<h4>Background</h4>The use of patient-reported outcome measures (PROMs) has become a mainstay of orthopedic joint arthroplasty research. Large studies with >1000 participants are vital to orthopedic research, as they allow for comprehensive multivariable analysis. Achieving high follow-up rates minimizes potential response bias. Maintaining adequate follow-up rates becomes more challenging as sample size increases. We aimed to systematically review the present literature to determine the follow- ...[more]

PMID: 31286051

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Project description:IntroductionHip and knee arthroplasties have revolutionised the management of degenerative joint diseases and, due to an ageing population, are becoming increasingly common. Follow-up of joint prostheses is to identify problems in symptomatic or asymptomatic patients due to infection, osteolysis, bone loss or potential periprosthetic fracture, enabling timely intervention to prevent catastrophic failure at a later date. Early revision is usually more straight-forward surgically and less traumatic for the patient. However, routine long-term follow-up is costly and requires considerable clinical time. Therefore, some centres in the UK have curtailed this aspect of primary hip and knee arthroplasty services, doing so without an evidence base that such disinvestment is clinically or cost-effective.MethodsGiven the timeline from joint replacement to revision, conducting a randomised controlled trial (RCT) to determine potential consequences of disinvestment in hip and knee arthroplasty follow-up is not feasible. Furthermore, the low revision rates of modern prostheses, less than 10% at 10 years, would necessitate thousands of patients to adequately power such a study. The huge variation in follow-up practice across the UK also limits the generalisability of an RCT. This study will therefore use a mixed-methods approach to examine the requirements for arthroplasty follow-up and produce evidence-based and consensus-based recommendations as to how, when and on whom follow-up should be conducted. Four interconnected work packages will be completed: (1) a systematic literature review; (2a) analysis of routinely collected National Health Service data from five national data sets to understand when and which patients present for revision surgery; (2b) prospective data regarding how patients currently present for revision surgery; (3) economic modelling to simulate long-term costs and quality-adjusted life years associated with different follow-up care models and (4) a Delphi-consensus process, involving all stakeholders, to develop a policy document which includes a stratification algorithm to determine appropriate follow-up care for an individual patient.Ethics and disseminationFavourable ethical opinion has been obtained for WP2a (RO-HES) (220520) and WP2B (220316) from the National Research Ethics Committee. Following advice from the Confidentiality Advisory Group (17/CAG/0122), data controllers for the data sets used in WP2a (RO-HES) - NHS Digital and The Phoenix Partnership - confirmed that Section 251 support was not required as no identifiable data was flowing into or out of these parties. Application for approval of WP2a (RO-HES) from the Independent Group Advising on the Release of Data (IGARD) at NHS Digital is in progress (DARS-NIC-147997). Section 251 support (17/CAG/0030) and NHS Digital approval (DARS-NIC-172121-G0Z1H-v0.11) have been obtained for WP2a (NJR-HES-PROMS). ISAC (11_050MnA2R2) approval has been obtained for WP2a (CPRD-HES).

Project description:A long-term follow-up was made of 12 elbows operated upon between 1971 and 1986, with more than 20 years' follow-up, in nine males and three females, age at the time of surgery between 10 and 19 years . Eight right and four left elbows were involved, and there were three aetiological causes. Seven cases were sequelae of elbow fractures, of which five were supracondylar and two were of the olecranon. There were four cases of juvenile rheumatoid arthritis and one was post-osteomyelitis. The surgical technique involved a modification made by Vainio of MacAusland's technique (wider resection of the osseous ends and total covering of the bloody surfaces) [5, 9]. After extirpating the tissue blocking the joint, we proceeded to remodel the distal humerus in a wide V shape, the proximal end of the ulnar and, if necessary, the radial head. The proximal end of the ulna was sectioned transversely. All surgery was carried out sub-periosteally. Then, an interposition material was placed in one piece and sutured over the distal humerus and cut ends of the ulna and radius. The articular ends were brought together, and the capsule was closed using equidistant stitching, as is the skin. A small compression bandage was applied, and the arm was immobilised with a collar and cuff sling, with the forearm flexed to slightly less than a right angle. In ten cases, the interposition material was fascia lata grafts; in one case, skin graft and in one case, Gelfoam graft. Early rehabilitation began when post-operative pain allowed. Follow-up ranged from 25 to 32 years. Pre-surgical movement ranged between 90 degrees and 120 degrees of flexion and 30 degrees and 90 degrees of extension. Post-operative range varied between 90 degrees and 150 degrees of flexion. The five cases of full pre-operative ankylosis achieved between 90 degrees and 150 degrees of flexion and between 0 degrees and 70 degrees of extension. The total range of motion at the latest follow-up varied from 35 degrees to 150 degrees . Patients who were able to perform flexion of 120 degrees or more were considered to be excellent, those between 90 degrees and 119 degrees were graded good, from 60 degrees to 89 degrees fair and those 59 degrees or less poor. The ability to attain a hand to mouth position requires a mobility of 120 degrees . We obtained excellent results in two patients, good results in three, fair results in four and poor results in three. The fascia lata was used in 83% of cases, obtaining excellent to good results in five patients (41%). Elbow interposition arthroplasty has its indications in children and adolescents where arthrodesis or total joint replacement cannot be performed.

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Arthroplasty studies with greater than 1000 participants: analysis of follow-up methods.

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Arthroplasty studies with greater than 1000 participants: analysis of follow-up methods.

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