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Predicting, Understanding and Speeding Recovery After TKA

NCT02685735 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-08-15

Study results available
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Summary

The objective of this research study is to better understand patterns of recovery after Total Knee Arthroplasty (TKA) amd Total Hip Replacement (THA). The study will evaluate how pain, activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate the efficacy of gabapentin versus placebo for improving recovery after surgery.

Conditions

  • Pain
  • Total Knee Replacement
  • Total Hip Replacement

Interventions

DRUG

Gabapentin

Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.

DRUG

Placebo

Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • James C Eisenach, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-02
Primary Completion
2022-02-09
Completion
2022-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02685735 on ClinicalTrials.gov